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Abstract Background In Japan dialyzers are classified as type I, II, III, IV, or V on the basis of the β 2-microglobulin clearance. In 2023, Type V dialyzers were defined as super high-flux membrane dialyzers. Herein, we investigate the association between dialyzer type and mortality. Methods A cohort study was conducted using the Japanese Society for Dialysis Therapy Renal Data Registry database from 31 December 2017, to 31 December 2019. We enrolled 181,879 patients on hemodialysis who were divided into type I–V groups per the Japanese classification. We assessed the associations of each group with 2-year all-cause mortality using Cox proportional hazard models. Furthermore, propensity score matching analysis was performed. Results By the end of 2019, 34,196 patients (18.8%) had died. The hazard ratio (95% confidence interval) was significantly higher in the type I (1.25 [1.12–1.39]), type II (1.21 [1.13–1.31]), and type III (1.07 [1.02–1.13]) groups and significantly lower in the type V group (0.86 [0.80–0.92] P

Abstract Dialyzers are classified into five types based on their β2-microglobulin clearance rate and albumin sieving coefficient: Ia, Ib, IIa, and IIb. In addition, a new classification system introduced a type S dialyzer. However, limited information is available regarding the impact of dialyzer type on patient outcomes. A cohort study was conducted using data from the Japanese Society for Dialysis Therapy Renal Data Registry database. Total 181,804 patients on hemodialysis (HD) were included in the study, categorized into four groups (type Ia, IIa, IIb, and S). The associations between each group and two-year all-cause mortality were assessed using Cox proportional hazard models. Furthermore, propensity score-matching analysis was performed. By the end of 2019, 34,185 patients on dialysis had died. After adjusting for all confounders, the risk for all-cause mortality was significantly lower in the type IIa, and S groups than in the type Ia group. These significant findings were consistent after propensity score matching. In conclusion, our findings suggest that super high-flux dialyzers, with a β2-microglobulin clearance of ≥ 70 mL/min, may be beneficial for patients on HD, regardless of their albumin sieving coefficient. In addition, type S dialyzers may be beneficial for elderly and malnourished patients on dialysis. Trial registration number: UMIN000018641

Abstract Background Plasmapheresis is an important preoperative desensitization treatment for ABO-incompatible living kidney transplantation. However, in cases with plasma exchange therapy (PET), it is necessary to consider the risks of perioperative bleeding and healthcare economic costs. This study investigated the association between intraoperative blood loss and the frequency of preoperative double-filtration plasmapheresis (DFPP) and explored the correlation between DFPP frequency and coagulation factors. Furthermore, the study examined the incidence of perioperative bleeding complications. Methods We enrolled 294 patients (205 men and 89 women) who underwent living kidney transplantation at our institution between January 2020 and March 2023, without PET or with only DFPP performed as PET. A single dose of rituximab (200 mg) was administered to ABO-incompatible living kidney transplant patients within 7 days before transplantation. In these patients, PET was performed until anti-blood group IgG and IgM antibody titers were reduced to 32 times or less. Results The intraoperative blood loss increased in accordance with the DFPP sessions. The amount of bleeding significantly increased when DFPP was performed ≥ 2 sessions. Considering this, we initiated serum fibrinogen level measurements from the middle of the study and observed that serum fibrinogen levels decreased in correlation with the number of DFPP sessions. Fibrinogen levels dropped to critical levels (

Abstract Background Approximately 16.4% of patients on hemodialysis (HD) in Japan are treated with intermittent infusion hemodiafiltration (I-HDF). However, large-scale data on clinical outcomes with this modality are lacking. This study aimed to compare the outcomes of I-HDF with those of conventional HD. Methods A cohort study was conducted using the Japanese Society for Dialysis Therapy Renal Data Registry database from December 31, 2017 to December 31, 2019. The subjects were 210,574 patients on maintenance HD. The exposure of interest was I-HDF treatment versus conventional HD. The I-HDF group was divided into two subgroups based on substitution: low-volume (

Abstract Background The 2020 Japanese Society for Dialysis Therapy Renal Data Registry (JRDR) annual survey was sent to 4493 dialysis facilities in Japan. Methods Questionnaires were sent to all facilities that provide patients with dialysis therapy in Japan. Data were collected and compiled to form cross-sectional results of renal replacement therapy from various aspects. Results In total, 4437 facilities (98.8%) responded to the facility questionnaire and 4271 (95.1%) responded to the patient questionnaire. The number of chronic dialysis patients in Japan continues to increase every year, reaching 347,671 at the end of 2020 and giving a prevalence rate of 2754 patients per million population. The mean age was 69.40 years. Diabetic nephropathy was the most common primary disease among the prevalent dialysis patients (39.5%), followed by chronic glomerulonephritis (25.3%) and nephrosclerosis (12.1%). There were 40,744 incident dialysis patients during 2020, representing a decrease of 141 from 2019. The average age of patients on dialysis was 70.88 years, with diabetic nephropathy being the most common underlying disease (40.7%) second most common was nephrosclerosis (17.5%), which was unchanged from the previous year and surpassed chronic glomerulonephritis (15.0%). There were 34,414 patient deaths in 2020; the crude mortality rate was 9.9%. The main causes of death were heart failure (22.4%), infection (21.5%), and malignancy (9.0%), which were almost the same as the percentages for the previous year. Since 2012, the number of patients treated by hemodiafiltration has increased rapidly; in 2020, the number of patients on this modality was 163,825, accounting for 47.1% of all patients on maintenance dialysis. The number of patients on peritoneal dialysis has been on the rise since 2017, reaching 10,338 in 2020; 20.8% of whom received combined therapy with hemodialysis or hemodiafiltration, showing no change from the previous year. A total of 751 patients were on home hemodialysis at the end of 2020, representing a decrease of 9 from the end of 2018. In 2020, coronavirus disease 2019 (COVID-19) infection and malignancy were added as new items in the survey. Continuing on from the 2019 survey, history of kidney donation for a living-donor transplant was investigated. Conclusions Present issues and challenges in renal replacement therapy were identified in the responses to the new questionnaire items included in this survey. A more detailed evaluation with adjustment for patient background factors should clarify the characteristics of the underlying diseases and conditions in dialysis patients. Trial registration The JRDR was approved by the Japanese Society for Dialysis Therapy ethics committee. It was registered in the University Hospital Medical Information Network (UMIN) Clinical Trials Registry on 10 September 2020 and in the UMIN clinical trials registration system (UMIN000018641).

Abstract In patients undergoing hemodialysis, the impact of atrial fibrillation (AF) through cardiac thromboembolism on the development of ischemic stroke may be influenced by the severity of atherosclerosis present. However, there are no large-scale reports confirming whether the severity of atherosclerosis influences the relationship between AF and stroke development in patients requiring hemodialysis. We aimed to investigate the effects of atherosclerotic disease on the relationship between AF and new-onset ischemic stroke. This nationwide longitudinal study based on dialysis facilities across Japan used data collected from the Japanese Renal Data Registry at the end of 2019 and 2020. The exposure was AF at the end of 2019, identified using a resting 12-lead electrocardiography. The primary outcome was the incidence of cerebral infarction (CI) after 1 year. To examine whether the number of atherosclerotic diseases modified the association between AF and the outcome, we estimated the odds ratios (ORs) using a logistic regression model and then assessed the presence of global interaction using Wald test. Following the study criteria, data from 151,350 patients (mean age, 69 years; men, 65.2%; diabetic patients, 48.7%) were included in the final analysis. A total of 9841 patients had AF (prevalence, 6.5%). Between 2019 and 2020, 4967 patients (3.2%) developed ischemic stroke. The adjusted OR of AF for new-onset CI was 1.5, which showed a decreasing trend with an increasing number of atherosclerotic diseases; the interaction was not significant (P = 0.34). While age, diabetes mellitus, smoking, systolic blood pressure, and serum C-reactive protein concentration were positively associated with CI, intradialytic weight gain, body mass index, and serum albumin level were negatively associated. While we demonstrated the association between AF and new-onset CI among Japanese patients on hemodialysis, we failed to demonstrate the evidence that the association was attenuated with an increasing numbers of atherosclerotic complications.

Abstract Background The Japanese Society for Dialysis Therapy is conducting the survey annually since 1968. The results provide a comprehensive picture of dialysis therapy in Japan. The survey for the year 2019 was performed as of December 2019. Methods Questionnaires were sent to all facilities that provide patients with dialysis therapy in Japan as an Excel file. Data were collected and compiled to form cross-sectional results of dialysis therapy from various aspects. Results At the end of 2019, the annual survey of the Japanese Society for Dialysis Therapy Renal Data Registry (JRDR) was conducted at 4487 dialysis facilities, of which 4411 facilities (98.3%) responded to the facility survey and 4238 facilities (94.5%) responded to the patient survey. The number of chronic dialysis patients in Japan continues to increase every year; it reached 344,640 at the end of 2019, and the prevalence ratio of dialysis patients was 2732 per million population. In the patient survey, the mean age of prevalent dialysis patients was 69.09 years. The most prevalent primary disease among prevalent dialysis patients was diabetic nephropathy (39.1%), followed by chronic glomerulonephritis (25.7%) and nephrosclerosis (11.1%). In 2019, there were 40,885 new patients on dialysis, an increase of 417 over 2018. The average age of incident dialysis patients was 70.42 years, and diabetic nephropathy (41.6%) was the most common cause. The second cause was nephrosclerosis, followed by glomerulonephritis. As 34,642 patients passed away in 2019, the crude mortality rate for the year was 10.1%. Heart failure (22.7%), infectious disease (21.5%), and malignancy (8.7%) were the three leading causes of death. Since 2012, the number of patients treated by hemodiafiltration (HDF) has increased substantially. The figure reached 144,686 by year's end, representing 42.0% of all dialysis patients. In 2019, the number of peritoneal dialysis (PD) patients was 9,920, a small rise from 2017. 19.2% of PD patients also received hemodialysis (HD) or HDF to compensate for the reduction in dialysis dosage or in fluid removal by PD alone (hybrid therapy). At the end of 2019, 760 patients received home HD therapy, an increase of 40 from 2018. In 2019, a detailed survey was conducted on the current status of CKD-MBD treatment, 10 years after the previous survey in 2009. The clinical efficacy of newly released medications during this time period and the impact of the 2012 revisions to the CKD-MBD guidelines require further investigation. These analyses would serve as the foundation for the next revision of the CKD-MBD guidelines and may reveal deeper therapeutic insights regarding CKD-MBD. Conclusions The results obtained by the survey revealed the comprehensive practice patterns of dialysis therapy and served as a basis for future guidelines. Trial registration: JRDR was approved by the ethics committee of JSDT (approval number 1–5) and registered in the "University hospital Medical Information Network (UMIN) Clinical Trials Registry" on 10th September 2019 with a clinical trial ID of UMIN000018641. https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000021578 (Accessed 20 November 2020).

BackgroundInformation of short-term prognosis after hemodialysis (HD) introduction is important for elderly patients with chronic kidney disease (CKD) and their families choosing a modality of renal replacement therapy. Therefore, we developed a risk score to predict early mortality in incident elderly Japanese hemodialysis patients.Materials and methodsWe analyzed data of incident elderly HD patients from a nationwide cohort study of the Japanese Society for Dialysis Therapy Renal Data Registry (JRDR) to develop a prognostic risk score. Candidate risk factors for early death within 1 year was evaluated using multivariate logistic regression analysis. The risk score was developed by summing up points derived from parameter estimate values of independent risk factors. The association between risk score and early death was tested using Cox proportional hazards models. This risk score was validated twice by using an internal validation cohort derived from the JRDR and an external validation cohort collected for this study.ResultsUsing the development cohort (n = 2,000), nine risk factors were retained in the risk score: older age (>85), yes = 2, no = 0; sex, male = 2, female = 0; lower body mass index (2.0 mg/dL), yes = 2, no = 0. In the internal and external validation cohorts (n = 739, 140, respectively), the medium- and high-risk groups (total score, 6 to 10 and 11 or more, respectively) showed significantly higher risk of early death than the low-risk group (total score, 0 to 5) (pConclusionWe developed a prognostic risk score predicting early death within 1 year in incident elderly Japanese HD patients, which may help detect elderly patients with a high-risk of early death after HD introduction.

Abstract Approximately 340,000 people in Japan are on chronic dialysis, and this number continues to increase. Even today, hemodialysis is the most frequently selected modality for renal replacement therapy in Japan, accounting for approximately 97% of chronic dialysis patients. This is because the facilities and insurance for hemodialysis were developed early in Japan, and the results of treatment were very good. Most cases of kidney disease are associated with diabetes or hypertension, and the average age of patients on dialysis is increasing, which means that many dialysis patients experience reduced activities of daily living (ADL) and quality of life (QOL). To address those issues, shared decision-making and advance care planning are now widely used in the process of selecting RRT. Because of the work required, including multiple processes and information sharing, medical professionals must practice team medicine in order to improve ADL and QOL for dialysis patients and renal transplant recipients as well as promote appropriate selection of RRT. Accordingly, the “Renal Replacement Therapy Professional Instructor” certification system was established to meet this need. In addition, due to the aging of dialysis patients, there are more situations where it is necessary to consider forgoing dialysis in terms of general condition and QOL. In such cases, conservative kidney management must be offered, and the “Renal Replacement Therapy Professional Instructor” is also required to participate in them. It is hoped that a comprehensive medical system centered around Renal Replacement Therapy Professional Instructors will be created to meet the increasingly diverse needs of patients with end-stage kidney disease and their families, with the aim of providing support that will enable them to lead richer lives.

Chronic kidney disease—mineral and bone disorder (CKD-MBD) is a systemic disorder that increases the risk of morbidity and mortality in dialysis patients. CKD-MBD is highly prevalent in dialysis patients, and appropriate treatment is important for improving their outcomes. Inorganic phosphate, fibroblast growth factor 23, parathyroid hormone, and calciprotein particles are markers for critical components and effectors of CKD-MBD, and higher circulating levels of these markers are linked to cardiovascular diseases. In this short review, we focus on the pathogenesis and management of CKD-MBD in CKD patients, especially those on dialysis therapy, and discuss the prospects for improving the management in CKD patients, including those on dialysis.

Abstract Frailty has become an emerging public health problem in the aging society and is regarded as a state of vulnerability to developing increased dependency and/or mortality when exposed to a stressor. As the proportion of elderly dialysis patients is increasing worldwide, frailty has recently influenced on the clinical outcomes among those patients also caused great attention. The prevalence of frailty among dialysis patients has ranged from 3.0- to 10-fold higher than in community-dwelling elderly. Since frailty has been found to be associated with higher mortality, independent of clinical characteristics and comorbidity, interventions to improve frailty have the potential to contribute to better quality of life and lower mortality among dialysis patients. Moreover, clinical research should be focused on the possibility that early rehabilitation of dialysis patients might improve poor outcomes. Current clinical question should aim to take an appropriate strategy to address frailty, including identifying the optimal timing for intervention.

Abstract Background Dialysis patients are predisposed to severe disease and have a high mortality rate in coronavirus disease 2019 (COVID-19) due to their comorbidities and immunocompromised conditions. Therefore, dialysis patients should be prioritized for vaccination. This study aimed to examine how long the effects of the vaccine are maintained and what factors affect antibody titers. Methods Hemodialysis patients (HD group) and age- and sex-matched non-dialysis individuals (Control group), receiving two doses of BNT162b2 vaccine, were recruited through the Japanese Society for Dialysis Therapy (JSDT) Web site in July 2021. Anti-SARS-CoV-2 immunoglobulin (IgG) (SARS-CoV-2 IgG titers) was measured before vaccination, 3 weeks after the first vaccination, 2 weeks after the second vaccination, and 3 months after the second vaccination, and was compared between Control group and HD group. Factors affecting SARS-CoV-2 IgG titers were also examined using multivariable regression analysis and stepwise regression analysis (least AIC). In addition, we compared adverse reactions in Control and HD groups and examined the relationship between adverse reactions and SARS-CoV-2 IgG titers. Results Our study enrolled 123 participants in the Control group (62.6% men, median age 67.0 years) and 206 patients in the HD group (64.1% men, median age 66.4 years). HD group had significantly lower SARS-CoV-2 IgG titers at 3 weeks after the first vaccination (p

Abstract Background Patients with coronavirus disease 2019 (COVID-19) who receive dialysis therapy develop more severe disease and have a poorer prognosis than patients who do not. Although various data on the treatment of patients not receiving dialysis therapy have been reported, clinical practice for patients on dialysis is challenging as data is limited. The Infection Control Committee of the Japanese Society for Dialysis Therapy decided to clarify the status of treatment in COVID-19 patients on dialysis. Methods A questionnaire survey of 105 centers that had treated at least five COVID-19 patients on dialysis was conducted in August 2021. Results Sixty-six centers (62.9%) responded to the questionnaire. Antivirals were administered in 27.7% of facilities treating mild disease (most patients received favipiravir) and 66.7% of facilities treating moderate disease (most patients with moderate or more severe conditions received remdesivir). Whether and how remdesivir is administered varies between centers. Steroids were initiated most frequently in moderate II disease (50.8%), while 43.1% of the facilities initiated steroids in mild or moderate I disease. The type of steroid, dose, and the duration of administration were generally consistent, with most facilities administering dexamethasone 6 mg orally or 6.6 mg intravenously for 10 days. Steroid pulse therapy was administered in 48.5% of the facilities, and tocilizumab was administered in 25.8% of the facilities, mainly to patients on ventilators or equivalent medications, or to the cases of exacerbations. Furthermore, some facilities used a polymethylmethacrylate membrane during dialysis, nafamostat as an anticoagulant, and continuous hemodiafiltration in severe cases. There was limited experience of polymyxin B-immobilized fiber column-direct hemoperfusion and extracorporeal membrane oxygenation. The discharge criteria for patients receiving dialysis therapy were longer than those set by the Ministry of Health, Labor and Welfare in 22.7% of the facilities. Conclusions Our survey revealed a variety of treatment practices in each facility. Further evidence and innovations are required to improve the prognosis of patients with COVID-19 receiving dialysis therapy.

Coronavirus disease 2019 (COVID-19), caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is now a pandemic. Although several treatment guidelines have been proposed for patients who have both inflammatory bowel disease and COVID-19, immunosuppressive therapy is essentially not recommended, and the treatment options are limited. Even in the COVID-19 pandemic, adjuvant adsorptive granulocyte and monocyte apheresis may safely bring ulcerative colitis (UC) into remission by removing activated myeloid cells without the use of immunosuppressive therapy. Our patient was a 25-year-old Japanese male with UC and COVID-19. This is the first case report of the induction of UC remission with granulocyte and monocyte apheresis treatment for active UC associated with COVID-19.

Abstract Background The Japanese Association of Dialysis Physicians, the Japanese Society for Dialysis Therapy, and the Japanese Society of Nephrology jointly established COVID-19 Task Force Committee and began surveying the number of newly infected patients. Methods This registry of the COVID-19 Task Force Committee was used to collect data of dialysis patients; a total of 1010 dialysis patients with COVID-19 were included in the analysis. Overall survival of patients was investigated with stratification by age group, complication status, and treatment. In addition, predictive factors for mortality were also investigated. The overall survival was estimated by Kaplan–Meier methods and compared by using log-rank test. Multivariate analysis was performed to identify the risk factor of mortality. For all statistical analyses, p

Abstract According to the annual survey of the Japanese Society for Dialysis Therapy Renal Data Registry (JRDR) conducted at the end of 2018, there were a total of 339,841 patients receiving dialysis (hereinafter, dialysis patients) in Japan. The survey included questions regarding the presence/absence of dementia, the performance status (PS), and the exercise habits of individual patients. The survey revealed that 10.8% of all dialysis patients had dementia (1.8% in the age group of less than 65 years, 6.8% in the age group of 65–74 years, and 22.7% in the age group of 75 years or older). These prevalences of dementia were approximately equal to those estimated from the survey conducted in 2010. Regarding PS, the percentage of patients with lower activity levels tended to be relatively high among patients who were less than 15 years old and those who were 60 years old or older. Concerning the exercise habits of dialysis patients, the percentage of patients who were classified as “not at all or hardly” in response to the question about exercise habit was the highest (60–80%) of all the exercise habit classifications in each of the age groups analyzed.

Abstract According to the annual survey of the Japanese Society for Dialysis Therapy Renal Data Registry (JRDR) conducted at the end of 2018, a total of 339,841 patients were receiving dialysis (hereinafter, dialysis patients) in Japan. This survey included an investigation of individual test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody (HCV-Ab), HCV-RNA, and serum alanine aminotransferase (ALT) (glutamic pyruvic transaminase [GPT]). The survey revealed that among dialysis patients in Japan, the prevalence of HBsAg positivity was 1.38% and the prevalence of HCV-Ab positivity was 4.7% at the end of 2018, both of which were markedly lower than the corresponding rates documented in 2007 (9.8% and 4.7%, respectively). The proportion of HCV-RNA-positive patients among all HCV-Ab-positive patients was 37.5%, which was also markedly lower than the percentage recorded in 2007 (64.0%). The prevalence of HBsAg positivity tended to increase as the dialysis vintage increased. The prevalence of HCV-Ab positivity was also not correlated with the dialysis vintage during the first 30 years of dialysis; however, it tended to increase as the dialysis vintage increased beyond the 30th year. Trial registration University hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000018641 . The JRDR was approved by the ethics committee of the JSDT (approval number 1-3) and was registered on August 8, 2015 (accessed June 2, 2020).

Abstract Background Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become a global pandemic affecting a variety of medical treatments, including hemodialysis. This study aims to investigate the implementation of infection control measures, to examine the shortage of personal protective equipment (PPE) and disinfectants, and to quantify the number of nosocomial COVID-19 transmissions in hemodialysis facilities in Japan during the pandemic. Methods We conducted a nationwide questionnaire survey between 20 October and 16 November 2020 (i.e., between the “second wave” and “third wave” in Japan) in the 4198 dialysis facilities of the Japanese Association of Dialysis Physicians and the Japanese Society for Dialysis Therapy. A total of 2227 facilities (53.0%) responded. The questionnaire consisted of (i) characteristics of facilities, (ii) infection prevention measures in routine dialysis practices, (iii) shortage of PPE, (iv) feasibility of various isolation measures, and (v) nosocomial transmission. Results Half of the responding facilities were hospitals with multiple departments, and the other half were clinics specialized in dialysis. Several infection prevention measures such as health checks of staff and patients, donning of masks before and after hemodialysis, and disinfection of frequently contacted areas were implemented during the COVID-19 pandemic. There was a significant improvement in the implementation rate of these measures during the pandemic, compared to before it, which reached over 90%. More than half of the facilities reported a shortage of disposable masks (67.2%) and hand sanitizer alcohol (56.7%). Isolation of COVID-19 patients in private rooms was possible only in 52.7% of the facilities. The majority of facilities (73.3%) could not accept COVID-19 dialysis patients due to lack of space and manpower. Nosocomial transmission of COVID-19 occurred in 4.0% of the facilities. Of those infected, 51.9% were staff. Conclusions This survey revealed that most hemodialysis facilities in Japan had improved implementation of infection control measures and had shortage of PPEs and disinfectants, though some facilities did not implement infection prevention measures adequately, mainly due to the limited space of the facility. It may be recommended that each facility immediately establishes isolation measures to prepare for the pandemic of COVID-19.

Introduction: Dipeptidyl peptidase-4 (DPP-4) has been hypothesized to improve responsiveness to erythropoiesis-stimulating agent (ESA). We aimed to describe the trend in DPP-4 inhibitor prescription patterns and assess the association between DPP-4 inhibitor prescription and ESA hyporesponsiveness (eHypo) in Japanese hemodialysis (HD) patients with diabetes mellitus (DM). Methods: We analyzed data from the Japan Dialysis Outcomes and Practice Patterns Study phase 4–6 (2009–2017) on patients with DM who underwent HD thrice per week for at least 4 months. The primary exposure of interest was having a DPP-4 inhibitor prescription. The primary analysis outcomes were a binary indicator of eHypo (mean hemoglobin 6,000 units/week over 4 months) and the natural log-transformed ESA resistance index (ERI). We used conditional logistic regression to compare within-patient changes in eHypo before and after initial DPP-4 inhibitor prescription. We used linear generalized estimating equation models to compare continuous ERI outcomes while accounting for within-patient repeated measurements with an exchangeable correlation structure. Results: There was a monotonic increase in DPP-4 inhibitor prescription according to study year up to 20% in 2017. Moreover, 12.8% of patients with a DPP-4 inhibitor prescription were ESA hyporesponsive before the initial DPP-4 inhibitor prescription. After DPP-4 inhibitor prescription, the odds of eHypo and mean log-ERI remained unchanged in the whole cohort of our study. The interaction analysis of DPP-4 inhibitor and sideropenia showed that DPP-4 inhibitors attenuated eHypo in the patients without iron deficiency. Conclusion: Our findings indicate a recent increase in DPP-4 inhibitor prescription among Japanese HD patients with DM. DPP-4 inhibitors could improve ERI in patients undergoing HD without iron deficiency.

Abstract The Oxford classification of IgA nephropathy (IgAN) can evaluate each MEST-C score individually. We analysed a new grading system that utilised the total MEST-C score in predicting renal prognosis. Altogether, 871 IgAN patients were classified into three groups using the new Oxford classification system (O-grade) that utilised the total MEST-C score (O-grade I: 0–1, II: 2–4, and III: 5–7 points), and the 10-year renal prognosis was analysed. The clinical findings became significantly severer with increasing O-grades, and the renal survival rate by the Kaplan–Meier method was 94.1%, 86.9%, and 74.1% for O-grades I, II, and III, respectively. The hazard ratios (HRs) for O-grades II and III with reference to O-grade I were 2.8 (95% confidence interval [CI] 1.3–6.0) and 6.3 (95% CI 2.7–14.5), respectively. In the multivariate analysis, mean arterial pressure and eGFR, proteinuria at the time of biopsy, treatment of corticosteroids/immunosuppressors, and O-grade (HR 1.63; 95% CI 1.11–2.38) were the independent factors predicting renal prognosis. Among the nine groups classified using the O-grade and Japanese clinical-grade, the renal prognosis had an HR of 15.2 (95% CI 3.5–67) in the severest group. The O-grade classified by the total score of the Oxford classification was associated with renal prognosis.

Abstract The annual survey questionnaires of the Japanese Society for Dialysis Therapy Renal Data Registry (JRDR) were sent to 4458 dialysis facilities at the end of 2018; 4402 facilities (98.7%) responded to the facility questionnaire, and 4222 facilities (94.7%) responded to the patient questionnaire. This paper reports the results obtained in regard to several issues: dialysis fluid quality, prescription of hemodialysis and hemodiafiltration, current status of peritoneal dialysis, and glycemic indices and treatment of diabetic patients.

Abstract Background It has been difficult to sufficiently achieve body-fluid management using blood volume (BV) monitor during hemodialysis (HD) with constant ultrafiltration (UF) rate. Recently, a relative BV change-guided UF control (BV-UFC) system was developed by combining the concepts of an automatic feedback system that could control the UF rate and profile with real- time monitoring of relative changes in BV (%ΔBV). However, this system has limited application in the clinical setting. Therefore, in this study, we aimed to perform the crossover study on HD with BV-UFC compared to standard HD in terms of hemodynamic stability during HD. Methods Forty-eight patients entered an 8-week crossover period of standard HD or HD with BV-UFC. Prevalence of intradialytic hypotension (IDH) as a primary outcome and changes in blood pressure (BP), differences in %ΔBV, and achievement of the target ultrafiltration volume as secondary outcomes were compared. IDH was defined as a reduction in systolic BP ≥20 mmHg from the baseline value at 10 min after HD initiation. Results No significant differences were found in the prevalence of IDH, frequency of intervention for symptomatic IDH, and achievement of the target ultrafiltration volume between the groups. The %ΔBV was significantly fewer (-12.1 ± 4.8% vs. -14.4 ± 5.2%, p

Abstract The annual survey of the Japanese Society for Dialysis Therapy Renal Data Registry (JRDR) was sent to 4458 dialysis facilities at the end of 2018; among these facilities, 4402 facilities (98.7%) responded to the facility questionnaire, and 4222 (94.7%) responded to the patient questionnaire. The number of chronic dialysis patients in Japan continues to increase every year; as of the end of 2018, it had reached 339,841 patients, representing 2688 patients per million population. Among the prevalent dialysis patients, the mean age was 68.75 years, and diabetic nephropathy was the most common primary disease among the prevalent dialysis patients (39.0%), followed by chronic glomerulonephritis (26.8%) and nephrosclerosis (10.8%). The number of incident dialysis patients was 40,468, and a reduction by 491 from 2017. The mean age of the incident dialysis patients was 69.99 years old. Diabetic nephropathy was also the most common primary disease (42.3%), representing a 0.2 percent point reduction from 2017. The distribution of diabetic nephropathy appears to have reached a plateau. The number of deceased patients during 2018 was 33,863, and the crude annual death rate was 10.0%. Heart failure was the most common cause of death (23.5%), followed by infection (21.3%) and malignant tumor (8.4%); these causes were similar to those for 2017. The number of patients receiving hemodiafiltration has been increasing since 2012, reaching 125,793 or 37.0% of all dialysis patients at the end of 2018. The number of patients receiving peritoneal dialysis has been gradually increasing since 2017, reaching 9445, and 19.7% of these patients were treated using a combination of peritoneal dialysis and hemodialysis or hemodiafiltration. The proportion of patients receiving combination therapy has remained at around 20% of all peritoneal dialysis patients. The number of patients undergoing home hemodialysis was 720, representing an increase of 36 patients from 2017. The 2018 JRDR survey included several topics such as the present status of the patient kinetics of chronic dialysis patients at the end of 2018, water treatment and hemodiafiltration, peritoneal dialysis, treatments for diabetes, mental and physical conditions, and the present status of viral hepatitis. In this paper, we describe the patient and facility kinetics. Trial registration The JRDR was approved by the ethics committee of the JSDT (approval number 1-3) and was registered in the “University hospital Medical Information Network (UMIN) Clinical Trials Registry” under the clinical trial ID of UMIN000018641 on August 8, 2015: (Accessed June 2, 2020)

Humoral and cellular responses are critical in understanding immune responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. Here, we evaluated these responses in hemodialysis (HD) patients after the booster vaccination. SARS-CoV-2 immunoglobulin (IgG) levels, neutralizing antibody titers, and the T-SPOT®.COVID test (T-SPOT) were measured prior to, three weeks after, and three months after the booster administration. The HD group had significantly higher SARS-CoV-2 IgG levels and neutralizing antibody titers against the original strain at three weeks and three months after the booster vaccination compared to the control group, albeit the HD group had lower SARS-CoV-2 IgG levels and neutralizing antibody titers before the booster administration. Moreover, the HD group had significantly higher T-SPOT levels at all three time points compared to the control group. The HD group also had significantly higher local and systemic adverse reaction rates than the control group. By booster vaccination, HD patients could acquire more effective SARS-CoV-2-specific humoral and cellular immunity than the control group.

Abstract The annual survey of the Japanese Society for Dialysis Therapy Renal Data Registry (JRDR) was conducted for 4413 dialysis facilities at the end of 2017; among which 4360 facilities (98.8%) responded to the facility questionnaire, and 4188 (94.9%) responded to the patient questionnaire. The response rate of the 2017 survey was comparable with the past, even though it was the third year after the new anonymization method. The number of chronic dialysis patients in Japan continues to increase every year; it has reached 334,505 at the end of 2017. The mean age was 68.43 years. The prevalence rate was 2640 patients per million population. Diabetic nephropathy was the most common primary disease among the prevalent dialysis patients (39.0%), followed by chronic glomerulonephritis (27.8%) and nephrosclerosis (10.3%). The rate of diabetic nephropathy and nephrosclerosis has been increasing year by year, whereas that of chronic glomerulonephritis was declining. The number of incident dialysis patients during 2017 was 40,959; it has remained stable since 2008. The average age was 69.68 years and diabetic nephropathy (42.5%) was the most common cause in the incident dialysis patients. These patients caused by diabetes did not change in number for recent several years. Further, 32,532 patients died in 2017; the crude mortality rate was 9.8%. The patients treated by hemodiafiltration (HDF) have been increasing rapidly from the revision of medical reimbursement for HDF therapy in 2012. It has attained 95,140 patients at the end of 2017, which were 18,304 greater than that in 2016. The number of peritoneal dialysis (PD) patients was 9090 in 2017, which had been slightly decreasing since 2014. Further, 19.4% of PD patients treated in the combination of hemodialysis (HD) or HDF therapy (hybrid therapy). And 984 patients were treated by home HD therapy at the end of 2017; it increased by 49 from 2016. Trial registration JRDR was approved by the ethical committee of JSDT (approval number 1-3) and has been registered in “University hospital Medical Information Network (UMIN) Clinical Trials Registry” as a clinical trial ID of UMIN000018641 at 8th August 2015. https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000021578 (Accessed 31 July 2019).

Background/Aims: Cross-classification analyses are rarely reported. We investigated the prognostic factors for chronic kidney disease (CKD) progression using a body mass index (BMI)-based cross-classification approach. Methods: Patients’ renal outcome (≥50% decline in the estimated glomerular filtration rate or end-stage renal disease) in each subcohort was examined. Results: The number of prognostic factors identified in the multivariate Cox analysis was smaller in the “BMI ≥25, female” and CKD stage 3 subcohorts than in other subcohorts. Prognostic factors identified in the “BMI ≥25, CKD stage 3” subcohort only comprised albuminuria and male sex, and those in the “BMI ≥25, female” subcohort only comprised albuminuria, hyperphosphatemia, and anemia. Albuminuria, kidney impairment, male sex, hyperphosphatemia, anemia, and increased pulse pressure × heart rate product (PP × HR; pulsatile stress) were stable renal prognostic factors in almost all subcohorts. On the other hand, the prognostic value of increased BMI, younger age, hypoalbuminemia, increased intact parathyroid hormone, and decreased estimated 24-h urinary potassium excretion (e24hUK) differed according to subcohort. BMI was positively associated with CKD progression in the “BMI ≥25, age ≥65 years” and “BMI ≥25, CKD stages 4–5” subcohorts, whereas it was negatively associated with CKD progression in the “BMI

Abstract In recent years, a concept of renal rehabilitation has become widely known among nephrology specialists, dialysis specialists, kidney transplantation specialists, rehabilitation specialists, nutrition specialists, guideline specialists, nurses, physiotherapists, and representatives of patients. Therefore, in order to make it clear the definition, methods, and effectiveness of renal rehabilitation in Japan, we launched Renal Rehabilitation Guideline Preparation Committee in 2016 as a part of works in the Japanese Society of Renal Rehabilitation, and created a guideline in accordance to the “Minds Handbook for Clinical Practice Guideline Development 2014”. Here, we report systematic reviews and recommendations of exercise therapies in patients with kidney diseases based on the guideline preparation committee works. Six recommendations for the condition of each kidney disorder, groups addressing nephritis/nephrosis, chronic kidney diseases, dialysis therapy, and kidney transplantation were created. All the recommendation grades were determined by a consensus conference participated in by representatives of patients and various professionals. The purpose of this report is to provide an evidence-based, best practice summary to optimize the quality, safety and efficacy, and availability of renal rehabilitation service, and to provide care for maximum patient prognosis, quality of life, and satisfaction.

Abstract Chronic kidney disease-mineral bone disorder (CKD-MBD) is a systemic disorder of mineral and bone metabolism. In patients undergoing peritoneal dialysis (PD), serum levels of calcium (Ca), phosphate (P), and parathyroid hormone (PTH) remain relatively constant, irrespective of the timing of treatment. This is because PD is a continuous blood purification procedure, and in this respect differs greatly from hemodialysis (HD), where the serum levels of these factors change following each dialysis session, and so pre-dialysis values are considered baseline values. Nevertheless, the target values for serum P, Ca, and PTH in PD patients are the same as those in HD patients. In PD patients, however, it is plausible to initiate correction of any of these values once any tendency towards worsening is observed, even if they are still within the upper limit of normal for HD patients. Restriction of dietary P intake, conservation of residual renal function for excretion of P, and prescription of an appropriate P binder are recommended to maintain the blood P level in the appropriate range. The use of a 2.5-mEq/L Ca concentration dialysate reduces the risk of hypercalcemia and allows correction of adynamic bone disease. Meanwhile, secondary hyperparathyroidism may progress in such cases. It is thus recommended that this factor be considered in prescribing this type of dialysate.

Whether the visceral-to-subcutaneous fat ratio (V/S ratio) is associated with renal prognosis in patients with chronic kidney disease (CKD) remains unclear. Furthermore, little is known about the effect of sex and the absolute amount of visceral fat accumulation such as visceral fat area (VFA) ≥100 cm2 on the V/S ratio in relation to renal prognosis. In this study, 200 patients with CKD were evaluated for renal prognosis. Survival analyses and logistic regression analyses were conducted, generating time-series pseudo-R2 values. The mean and percent change of the pseudo-R2 values from the 6th year to the 10th year (6Y-10Y Mean and 6Y-10Y Change, respectively) were calculated for determining the cut-off points for the medium-term renal prognosis. Multivariate Cox regression analysis revealed that the V/S ratio was significantly associated with renal outcomes and that the VFA category (VFA ≥ 100 cm2) had significant interactions with the V/S ratio regarding renal prognosis. The hazard ratio (HR) of the V/S ratio was higher in the sub-cohort of VFA < 100 cm2 than in the sub-cohort of VFA ≥ 100 cm2 (HR: 6.42 vs. 1.00). Regarding sex differences, a strong association was noted between the V/S ratio and renal prognosis in women but not in men (HR: 2.40 vs. 1.10). On the other hand, 6Y-10Y Mean of the pseudo-R2 values indicated differences in the cut-off points of the V/S ratio between men and women (V/S ratio: 0.75 vs. 0.5). Our findings indicate that it may be clinically meaningful to consider the differences in sex and the amount of VFA ≥100 cm2 for the V/S ratio in relation to renal outcomes in patients with CKD. The 6Y-10Y Mean of the pseudo-R2 values contributed to determining the cut-off points of the V/S ratio according to the sex difference.

Abstract ᅟ The annual survey of The Japanese Society for Dialysis Therapy Renal Data Registry (JRDR) was conducted for 4396 dialysis facilities at the end of 2016, among which 4336 facilities (98.6%) responded. The response rate of the 2016 survey was comparable with the past, even though it was the second year after the new anonymization method. The number of chronic dialysis patients in Japan continues to increase every year; it has reached 329,609 at the end of 2016. The mean age was 68.15 years. The prevalence rate was 2597 patients per million population. Diabetic nephropathy was the most common primary disease among the prevalent dialysis patients (38.8%), followed by chronic glomerulonephritis (28.8%) and nephrosclerosis (9.9%). The rate of diabetic nephropathy and nephrosclerosis has been increasing year by year, whereas that of chronic glomerulonephritis was declining. The number of incident dialysis patients during 2016 was 39,344; it has remained stable since 2008. The average age was 69.40 years, and diabetic nephropathy (43.2%) was the most common cause in the incident dialysis patients. These patients caused by diabetes did not change in number for recent several years. Thirty-one thousand six hundred eight patients died in 2016; the crude mortality rate was 9.7%. The patients treated by hemodiafiltration (HDF) have been increasing rapidly from the revision of medical reimbursement for HDF therapy in 2012. It has attained 76,836 patients at the end of 2016, which were 21,503 greater than that in 2015. The number of peritoneal dialysis (PD) patients was 9021 in 2016, which had been slightly decreasing since 2014; 20.3% of PD patients treated in the combination of hemodialysis (HD) or HDF therapy. Six hundred thirty-five patients were treated by home HD therapy at the end of 2016; it increased by 63 from 2015. Trial registration JRDR was approved by the ethical committee of JSDT and has been registered in “University hospital Medical Information Network (UMIN) Clinical Trials Registry” as an approved number of UMIN000018641 on August 8, 2015.

Background/Aims: Aortic arch calcification (AoAC) is frequently detected in maintenance hemodialysis (MHD) patients and is associated with cardiovascular and all-cause mortality. We investigated the factors associated with AoAC and analyzed the relationship between the factors including bone-derived biomarkers and AoAC. Methods: We enrolled 389 stable MHD patients. AoAC was assessed using chest-X ray examination. Demographic data was collected in addition to serum levels of biochemical and bone-derived biomarkers, including sclerostin and fibroblast growth factor-23 (FGF-23). Results: Two hundred sixteen patients (55.5%) had AoAC. Patients with AoAC score ≥ 4 were older, with a higher percentage being male, and exhibited lower serum levels of albumin and triglyceride. Serum FGF-23 levels were inversely associated with AoAC severity, and FGF-23was directly related to vascular calcification. Age, gender, and dialysis vintage were independent predictors of AoAC. Conclusion: MHD patients have a high prevalence of AoAC. The grade of AoAC was dependent on older age in association with longer dialysis vintage. Levels of circulating FGF-23 but not sclerostin were related to AoAC severity. Serum FGF-23 levels were independently associated with AoAC.

Background/Aims: Potential relationships between serum sclerostin levels and the levels of bone metabolic markers in maintenance hemodialysis (MHD) patients have yet to be evaluated. This study sought to determine whether serum sclerostin levels are associated with mortality in MHD patients. Methods: We measured serum sclerostin levels in a Japanese MHD cohort, classified the patients into tertiles according to these levels, and followed their course for a 42-month period. Results: The cohort consisted of 389 MHD patients and there were 75 deaths. Kaplan-Meier analyses showed that the tertile of serum sclerostin was not associated with mortality risk. Cox analyses showed that there were no significant associations between serum sclerostin level and mortality. Conclusion: Serum sclerostin level was not an independent predictor of mortality in MHD patients after adjustment for several confounders. However, whether clinical interventions to modulate serum sclerostin levels in MHD patients would improve their survival remains to be determined.

Abstract Background Nutritional therapy and exercise training (ET) are important interventions for hemodialysis patients. We investigated the status of nutritional therapy and ET provided at hemodialysis facilities across Japan. Method This was a cross-sectional study. The facilities investigated were 3993 facility member institutions of the Japanese Society for Dialysis Therapy in August 2015. Data was collected on the facility type, number of staff (doctors, nurses, and medic al engineers), presence of staff (clinical dietitians, pharmacists, and physical therapists), proportion of elderly patients (age ≥ 65 years), patients with albumin ≤ 3.5 g/dL, and types of oral nutritional supplements (ONS), intradialytic parenteral nutrition (IDPN), and ET in the facility. We summarized data on facilities and patient characteristics and calculated the proportion of the nutrition that were ONS, IDPN, and exercise interventions provided. We used multiple logistic analyses to examine the facility characteristics associated with the provision of nutritional support and ET. Results We obtained responses from 1048 facilities (response rate 26.2%) and 88,492 patients (27.6%). Patients aged ≥ 65 years accounted for 63.4% of all investigated patients. Patients with Alb ≤ 3.5 g/dL accounted for 37.6% of all investigated patients. Meals during hemodialysis sessions were provided at 601 facilities (64%), ONS were used at 382 facilities (40%), and IDPN was administered at 471 facilities (46%). Exercise during hemodialysis sessions was provided at 190 facilities (20%). These trends did not change after adjustment of response rates by affiliations of facility type and region. At the patient level, only a limited number of patients were provided with ONS, IDPN, and ET, 2.1, 2.7, and 3.0%, respectively. ONS and IDPN were less likely to be offered in hospitals than in clinics without beds (odds ratio (OR) 0.21; 95% confidence interval (CI) 0.09–0.45) (OR 0.37; 95% CI 0.17–0.82). ET was also less likely to be offered in hospitals (OR 0.20; 95% CI 0.08–0.49). Conclusions Nutritional support therapy is provided in a considerable number of hemodialysis facilities, ET is increasing but offered by fewer facilities compared to other countries, while a limited number of patients were provided with ET.

Abstract Frailty is a clinical state in which there is an increase in the individual’s vulnerability to developing increased dependency and/or mortality when exposed to a stressor. Since the mean age of dialysis patients is increasing worldwide, frailty has recently come to be considered one of the risk factors for mortality in the older dialysis population. The prevalence of frailty among dialysis patients has ranged from 3.0- to 10-fold higher than that among community-dwelling elderly, depending on the method of assessing frailty and patient characteristics. Since frailty has been found to be associated with higher mortality, independent of clinical characteristics and comorbidity, interventions to improve frailty have the potential to contribute to better quality of life and lower mortality among dialysis patients. In addition, greater attention should be focused on the possibility that early rehabilitation of dialysis patients might improve poor outcomes. Clinical research should aim to devise an adequate strategy to address frailty, including identifying the optimal timing for intervention.

Abstract The number of older dialysis patients is increasing in many countries. For example, the trend is linked to the increase in the dialysis patients 70 years of age and over in Japan. Older dialysis patients often experience deteriorating physical and psychological functions, and special consideration for older patients has been focused on improving or preventing such deteriorations. On the other hand, from the standpoint of clinical studies, the distribution of clinical parameters, clinical outcomes, and their associations of older dialysis patients differ from those of younger patients. Moreover, they exhibit heterogeneous phenotypes. Health age may be more important than the chronological age in considering older patients. Since the age is the most powerful predictor of survival, clinical interventions might have little benefit on the very old dialysis patients. Therefore, maintaining the quality of life or activity of daily living might surpass survival regarding the goal of management of very old dialysis patients. Above all, individualized management according to the heterogeneity or health age are necessary for the older dialysis patients. Future clinical studies of older dialysis patients are needed for the better understanding of this population.

Abstract Background The Scientific Academy Committee of Japanese Society for Dialysis Therapy (JSDT) has developed 14 clinical practice guidelines (CPGs) and their revised editions independently or in cooperation with other organizations and translated many of them into English to make them available to the world. These guidelines were presented in a user-friendly textbook-like format and were useful for many healthcare professionals engaged in dialysis therapy. However, because the definition and the process for developing CPGs have recently become more rigorous worldwide, the conventional process of development and the format of JSDT no longer meet the requirements for CPGs. Method Since 2012, JSDT, with its Guideline Developing Working Group (formerly Guideline Subcommittee), had evaluated several CPGs developing systems. The working group evaluated the advantages and disadvantages of several CPGs developing systems. The most important point of them which JSDT would adopt for their own system was to be based on evidence and be able to receive international recognition. Results In Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) system, the quality of evidence was evaluated by systematic review on each clinical outcome by systematic review panel. After the report from the systematic review panel, the CPG panel grades the strength of recommendation on each CPG statement. GRADE system was the most frequently used for developing CPGs by many human healthcare societies in the world. If JSDT adopt GRADE system, it is necessary for us to learn how to assess the quality of evidence through a systematic review, to develop a system for determining the strength of recommendation on the basis of a systematic review, and to decide how to manage any conflicts of interest. Conclusions JSDT should provide the useful information from Japanese experiences on chronic dialysis to the world. In order to achieve this aim, we concluded that the most reasonable approach is to utilize the data from JSDT Renal Data Registry in a more creative manner, publish such data for the world as evidence, and develop CPGs in accordance with a globally recognized methodology, GRADE. Notification The current manuscript is the position statement of JSDT for developing future CPGs and the second publication of “Policy for Developing Clinical Practice Guidelines (CPGs) of the Japanese Society for Dialysis Therapy” on J Jpn Soc Dial Ther 2016; 49: 453-62 (in Japanese), with permission.

Abstract Background Since 2009, the peritoneal dialysis (PD) registry has been carried out as part of Japanese Society for Dialysis Therapy (JSDT) Renal Data Registry with the cooperation of Japanese Society for Peritoneal Dialysis. In this study, the current status of PD patients is reported on the basis of the results of the survey conducted at the end of 2014. Methods The subjects were PD patients who lived in Japan and participated in the 2014 survey. Descriptive analysis was performed for various items including the current status of the combined use of PD and another dialysis modalities such as hemodialysis or hemodiafiltration, the method of exchanging PD fluid, the use of an automated peritoneal dialysis machine, and the incidences of peritonitis and catheter exit-site infection. Results From the results of the facility survey in 2014, the number of PD patients was 9255, a decrease of 137 from that in 2013. Among the entire dialysis patient population, 2.9% were PD patients, a decrease of 0.1%. One thousand thirteen (21%) among them were on the combination therapy of PD and hemodialysis or hemodiafiltration. The mean incidence of peritonitis was 0.21 per patient per year in another expression as once per 57.1 patients per month. The mean incidence of catheter exit-site infection was 0.40 per patient per year in the other expression as once per 30.0 patients per month. Conclusions The number of PD patients has been stable around 9000~10,000 in these 10 years. High percentage of the combination therapy of PD and other dialysis modality and the lower PD dialysis dose was a unique point of the current PD in Japan. The patient’s and center’s peritonitis rates were very low as around 0.2 per patient-year. PD registry clearly showed the current trends in PD in Japan which were a little different from those in other many countries. Trial registration JSDT renal data registry was approved by the ethical committee of JSDT and registered in “University hospital Medical Information Network (UMIN) Clinical Trials Registry” as an approved number of UMIN000018641 in 2015.

Background: Serum phosphate levels, which are associated with the progression of renal dysfunction in chronic kidney disease, in patients with autosomal dominant polycystic kidney disease (ADPKD) are lower than those in patients with other kidney diseases. However, their role in ADPKD remains unclear. This study aimed to determine whether serum phosphate levels could have an association with renal prognoses among patients with ADPKD. Methods: In total, 55 patients with PKD1 or PKD2 mutations but not undergoing dialysis were evaluated. Data regarding serum phosphate levels were collected, and Cox regression analyses were used to calculate hazard ratios (HRs) with renal replacement therapy as the endpoint. Results: The median (quartile 1; quartile 3) serum phosphate concentration was 3.4 (3.1; 3.9) mg/dL, and the estimated glomerular filtration rate (eGFR) was 39.5 (17.6; 65.7) mL/min/1.73 m2. The multivariate analysis that included age, PKD1 mutation, eGFR, urinary protein excretion, hyperuricemia, and serum phosphate determined that eGFR (HR, 0.82; 95% confidence interval (CI), 0.74−0.90; p < 0.0001) and serum phosphate (HR, 6.78; 95% CI, 1.94−34.02; p = 0.0021) were independently associated with renal replacement therapy. Conclusions: We found that serum phosphate levels were significantly associated with poor renal prognoses in patients with ADPKD.

We performed post-marketing surveillance to evaluate the safety and efficacy of cell-free and concentrated ascites reinfusion therapy (CART). In total, 356 CART sessions in 147 patients at 22 centers were performed. The most common primary disease was cancer (128 cases, 300 sessions). Mean amount of ascites collected was 3.7 L, and mean concentration ratio was 9.2. Mean amount of reinfused protein was 67.8 g (recovery rate, 72.0%). Performance status, dietary intake, urine volume, body weight and abdominal circumference were significantly improved after CART. Body temperature increased significantly, by 0.3°C on average. Concomitant steroids and/or NSAIDs use before reinfusion was significantly and negatively associated with increases in body temperature. Most adverse events were fever and chills. This study examined a large number of patients compared with previous studies, and showed that CART is an effective and relatively safe treatment for refractory ascites, such as malignant ascites.

[This corrects the article DOI: 10.1371/journal.pone.0156951.].

BACKGROUND:Although dialysis is typically started in an effort to prolong survival, mortality is reportedly high in the first few months. However, it remains unclear whether this is true in Japanese patients who tend to have a better prognosis than other ethnicities, and if health conditions such as functional status (FS) at initiation of dialysis influence prognosis. METHODS:We investigated the epidemiology of early death and its association with FS using Japanese national registry data in 2007, which included 35,415 patients on incident dialysis and 7,664 with FS data. The main outcome was early death, defined as death within 3 months after initiation of hemodialysis (HD). The main predictor was FS at initiation of HD. Levels of functional disability were categorized as follows: severe (bedridden), moderate (overt difficulties in exerting basic activities of daily living), or mild/none (none or some functional disabilities). RESULTS:Early death remained relatively common, especially among elderly patients (overall: 7.1%; those aged ≥80 years: 15.8%). Severely and even only a moderately impaired FS were significantly associated with early death after starting dialysis (adjusted risk ratios: 3.93 and 2.38, respectively). The incidence of early death in those with impaired FS increased with age (36.5% in those with severely impaired FS and aged ≥80 years). CONCLUSIONS:Early death after starting dialysis was relatively common, especially among the elderly, even in Japanese patients. Further, early death was significantly associated with impaired FS at initiation of HD.

BACKGROUND/AIMS:The associations between phosphate, calcium, and intact parathyroid hormone (PTH) levels and composite cardiovascular end points have been studied. This study examined the associations of these markers with myocardial infarction (MI) and stroke separately. METHODS:This is a longitudinal study on 65,849 hemodialysis patients from the Japan Renal Data Registry. Patients with prior events at baseline were excluded. Predictors were phosphate, albumin-corrected calcium, intact PTH, and calcium times phosphate product levels. Outcome was the first episode of MI or stroke during a 1-year observation period. Data were analyzed using multiple logistic regression analyses, adjusted for potential confounders. RESULTS:There were 1,048, 651, and 2,089 events of incident MI, hemorrhagic, and ischemic stroke, respectively. Incident MI was associated with phosphate levels ≥6.5 mg/dL (odds ratio 1.49; confidence interval 1.23-1.80) compared with phosphate levels of 4.7-5.4 mg/dL and intact PTH levels>500 pg/mL (1.35; 1.03-1.79) compared with intact PTH levels of 151-300 pg/mL. Higher albumin-corrected calcium level was positively associated with MI (p = 0.04 by trend analysis). Hemorrhagic stroke was associated only with intact PTH levels>500 pg/mL (1.54; 1.10-2.17). Incident ischemic stroke had no association with phosphate, calcium, or intact PTH levels. The association of calcium times phosphate product with outcomes was essentially the same pattern as that of phosphate and outcomes. CONCLUSIONS:MI was associated with phosphate, calcium, and intact PTH levels, whereas hemorrhagic stroke was associated only with intact PTH. Ischemic stroke was not associated with any of them. The potential distinct beneficial effect on MI and stroke by managing bone and mineral disease should be investigated in future studies.

Hemodialysis removes solutes uniformly according to their molecular weight. During each hemodialysis session, 6–8 g of amino acids are reportedly removed into the dialysate. Little is known about the amount of amino acids removed from those who have undergone intradialytic parenteral nutrition (IDPN). Objective: We measured amino acid amounts prospectively during hemodialysis treatment. Methods: We used 200 ml of 7.2% amino acid solution (KidminTM), 200 ml of 50% glucose, and 20% of lipid emulsion as IDPN fluid. Blood samples were collected at the beginning and end of each session. The dialysate portion was also collected. Results: Six patients were included in this study after providing written informed consent. The amount of amino acids removed during hemodialysis sessions was calculated as 9.1±1.4 g, which was less than that infused as IDPN. The profiles of the removed amino acids showed that the amount removed was less than that within IDPN. However, for tyrosine and alanine, hemodialysis treatment removed more amino acids than that infused as IDPN, as well as amino acids that were not IDPN solution constituents. During a 2-week follow-up period, no significant change in amino acid profiles was observed. Conclusions: IDPN entirely supplemented the removed amino acids, although some amino acids were not restored.

Better nutritional status and early initiation of dialysis had been considered one of the most important methods for better prognosis of dialysis patients. In this study, we analyzed the effects of nutritional status, renal function at the start of renal replacement therapy (RRT), and co morbidity on 12-month survival of ESRD patients. The subjects in this study were 9695 new ESRD patients who started RRT in 2007 in Japan. The average age of the subjects was 67.5 years, 64.1% of the subjects were male, and 42.9% had diabetes. During the 12-month period after the start of RRT, 1546 patients died, and 35 patients received renal transplantation. Average estimated glomerular filtration rate (eGFR) at the initiation of dialysis was 6.52+ 4.20 mL/min/1.73 m2. Average serum albumin was significantly higher (P