Search

Background: The aim of the study was to assess bioavailability aspects of tacrolimus formulations during conversion from twice-daily (TAC BID) to once-daily (TAC OD) formulation in 89 stable kidney transplant recipients., Materials and Methods: The study included 89 stable kidney transplant recipients transplanted between 1998 and 2008 (37 female, 52 male, aged 46.0 ± 12.4 years) and followed for 10 years. For a comprehensive comparison of the different tacrolimus formulations, dose-normalized trough levels (ng/mL/mg total daily dose, C/D ratio) and their variability were studied for 10 consecutive visits before and 6 months after conversion., Results: The mean trough level decreased significantly 14 days after conversion (16%, 5.77 ± 1.94 [5.6, 4.5-6.5] ng/mL, P < .001). There was no significant difference between the tacrolimus trough levels before and 3 months after conversion (6.92 ± 1.89 [6.8, 5.9-8.0] ng/mL, P = .548). The tacrolimus daily dose 3 months after conversion (4.56 ± 1.81 [4.5, 3.5-5.5] mg/d) was significantly higher than the dose before conversion (4.16 ± 1.80 [4.0, 3.0-5.0] mg/d, P = .006). The post-conversion mean TAC trough level (10 measures) (6.6 [6.2-7.0] ng/mL) was similar to preconversion level (6.8 [5.6-7.9] ng/mL, P = .203). C/D ratio as well as C/D intrapatient variability (CV%) did not change during conversion (C/D 1.68 [1.36-2.53] vs 1.74 [1.41 vs 2.31], P = .075; CV% 19.5 [16.4-26.6] vs 24.4 [17.5-28.3], P = .114)., Conclusions: Conversion from TAC BID to TAC OD is associated with a significant increase in tacrolimus dose during the first 3 months. In a long-term observation both formulations present similar dose-normalized trough levels and variability., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Kidney transplantation (KTx) markedly reduces mortality in patients with end-stage kidney disease (ESKD) caused by type 1 diabetes mellitus (T1DM). The outstanding issue is whether transplantation should be limited only to KTx, with further insulinotherapy, or combined with pancreas transplantation in patients with ESKD/T1DM. The goal of this study was to compare the results of simultaneous pancreas-kidney transplantation (SPKTx) and deceased donor KTx and to identify factors affecting patient and kidney graft survival in patients with ESKD/T1DM., Methods: Eighty-seven deceased donor KTx and 66 SPKTx operated on in the Silesia region of Poland between 1998 and 2013 were included in the retrospective analysis., Results: During the mean 6.7 ± 3.6 years of follow-up, fewer cardiovascular episodes were observed in SPKTx recipients than in KTx recipients (1.5% vs 12.6%; P < .05). Five-year patient survival (80.7% in SPKTx vs 77.5% in KTx) and kidney graft survival (66.1% in SPKTx vs 70.4% in KTx) did not differ between study groups. There were no differences in patient survival (log-rank test, P = .99) or kidney graft survival (P = .99) based on Kaplan-Meier curves. Multivariable Cox proportional hazard analysis failed to identify factors explaining patient and kidney graft survival. Five-year pancreas graft survival was 58.9%. SPKTx recipients had significantly higher estimated glomerular filtration rates during the 7-year posttransplant period and less frequently developed proteinuria (6.1% vs 23%; P < .01)., Conclusions: Pancreas transplantation reduced cardiovascular risk and prevented the development of proteinuria but did not improve patient and kidney graft survival in recipients with T1DM in the 7-year follow-up period., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: The beneficial influence of kidney (KTx) or simultaneous pancreas and kidney transplantation (SPK) on quality of life (QOL) in patients with end-stage kidney disease caused by type 1 diabetes mellitus was confirmed in many studies. The aim of this study was to identify factors that influence QOL of patients in long-term follow-up after SPK or KTx., Methods: Twenty-seven SPK and 26 KTx patients with good function of transplanted organs at least 1 year after transplantation were enrolled into the analysis. To estimate QOL of the recipients the Kidney Disease and Quality of Life Short Form was applied., Results: Within the whole analyzed group, the necessity of exogenous insulin administration correlated (P < .05) with symptom/problem list (γ = -0.35), effects of kidney disease (-0.38), cognitive function (-0.47), sleep (-0.42), overall health (-0.47), physical functioning (-0.61), role-physical (-0.32), pain (-0.50), general health (-0.32), emotional well-being (-0.31), role-emotional (-0.36), social function (-0.33), energy/fatigue (-0.44), and the SF-12 physical composite (-0.44). History of cardiovascular episode correlated (P < .05) with symptom/problem list (γ = -0.59), effects of kidney disease (-0.46), burden of kidney disease (-0.56), sleep (-0.54), social support (-0.51), physical functioning (-0.55), role-physical (-0.70), pain (-0.60), general health (-0.57), emotional well-being (-0.45), role-emotional (-0.95), social function (-0.58), energy/fatigue (-0.59), SF-12 physical composite (-0.45), and SF-12 mental composite (-0.83)., Conclusions: Exogenous insulin administration and history of cardiovascular episode are the most important factors influencing QOL in patients after SPK or KTx, particularly worsening its physical components., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Introduction: Simultaneous pancreas-kidney transplantation (SPK) is an alternative to kidney transplantation (KTx) for type 1 diabetic patients with end-stage kidney disease. However, a fair comparison of SPK and KTx is difficult because of significant differences in donor, recipient, and transplantation procedure parameters. The aim of this study was to compare the early and long-term outcomes of SPK versus KTx in southwest Poland., Material and Methods: Thirty-five diabetic dialysis patients who had SPK and 64 patients who had KTx were included in the analysis., Results: SPK recipients were younger (38±6 years versus 42±9 years) and received organs from younger donors (25±7 versus 43±12 years) compared to the KTx group. They had shorter kidney cold ischemia time (9±2 hours versus 22±7 hours) but worse HLA class II mismatches (1.4±0.6 versus 1.0±0.5). In the early postoperative period, three patients died from the SPK group and one patient died from the KTx group. Additionally, two SPK patients lost their pancreatic grafts, and five KTx patients lost their kidney grafts. One-year patient survival rates for the SPK and KTx groups were 88% and 98%, respectively, and 5-year, 81% and 93%, respectively. One-year kidney graft survivals rates for the SPK and KTx groups were 100% and 89%, respectively, and 5-years, 89% and 81%, respectively. One-year insulin-free survival among SPK patients was 90% and the 5-year survival rate was 76%. Excretory function of the transplanted kidneys was better among SPK group; however, the difference reached statistical significance only in posttransplant years 2 and 3: 63.5±20.1 versus 50.3±19.7 and 64.9±12.9 versus 51.6±21.8 mL/min/1.73 m2 for SPK and KTx, respectively., Conclusions: Normoglycemia in SPK recipients did not improve patient survival at 5 years. The worse HLA compatibility in the SPK group did not lead to impaired kidney graft survival compared to KTx. Better kidney graft function among SPK recipients probably resulted from a more restrictive donor selection., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Despite the fact that concentrations of mycophenolic acid (MPA) are not routinely measured, accumulating data suggest the usefulness of this monitoring to optimize therapy. The aim of this study was to assess the influence of CsA and tacrolimus on MPA pharmacokinetics. Concentrations of MPA were measured using HPLC. An assay was performed before dose (the C(0)), as well as at 40 minutes and 1, 2, 4, 6, 8, 10, 12 hours after administration of mycophenolate mofetil (MMF). MPA profiles were assessed in 51 patients receiving tacrolimus at a dose of 1.0 g/d and prednisone as well as in 97 patients receiving CsA (2.0 g/d) and prednisone. Significant correlations of MPA levels with serum albumin and GFR were observed in both groups. Women presented with higher levels of MPA than men. C(0) MPA level among the tacrolimus group were significantly higher than those in CsA group: 3.18 +/- 2.21 microg/mL versus 1.68 +/- 1.03 microg/mL (P