Search

Background: COVID-19 is associated with increased morbidity and mortality in patients with chronic kidney disease (CKD) stages G4-G5, on dialysis or after kidney transplantation (kidney replacement therapy, KRT). SARS-CoV-2 vaccine trials do not elucidate if SARS-CoV-2 vaccination is effective in these patients. Vaccination against other viruses is known to be less effective in kidney patients. Our objective is to assess the efficacy and safety of various types of SARS-CoV-2 vaccinations in patients with CKD stages G4-G5 or on KRT.Methods: In this national prospective observational cohort study we will follow patients with CKD stages G4-G5 or on KRT (n = 12,000) after SARS-CoV-2 vaccination according to the Dutch vaccination program. Blood will be drawn for antibody response measurements at day 28 and month 6 after completion of vaccination. Patient characteristics and outcomes will be extracted from registration data and questionnaires during 2 years of follow-up. Results will be compared with a control group of non-vaccinated patients. The level of antibody response to vaccination will be assessed in subgroups to predict protection against COVID-19 breakthrough infection.Results: The primary endpoint is efficacy of SARS-CoV-2 vaccination determined as the incidence of COVID-19 after vaccination. Secondary endpoints are the antibody based immune response at 28 days after vaccination, the durability of this response at 6 months after vaccination, mortality and (serious) adverse events.Conclusion: This study will fulfil the lack of knowledge on efficacy and safety of SARS-CoV-2 vaccination in patients with CKD stages G4-G5 or on KRT.Trial Registration: The study protocol has been registered in clinicaltrials.gov ( NCT04841785 ). Current knowledge about this subject COVID-19 has devastating impact on patients with CKD stages G4-G5, on dialysis or after kidney transplantation. Effective SARS-CoV-2 vaccination is very important in these vulnerable patient groups. Recent studies on vaccination in these patient groups are small short-term studies with surrogate endpoints. Contribution of this study Assessment of incidence and course of COVID-19 after various types of SARS-CoV-2 vaccination during a two-year follow-up period in not only patients on dialysis or kidney transplant recipients, but also in patients with CKD stages G4-G5. Quantitative analysis of antibody response after SARS-CoV-2 vaccination and its relationship with incidence and course of COVID-19 in patients with CKD stages G4-G5, on dialysis or after kidney transplantation compared with a control group. Monitoring of (serious) adverse events and development of anti-HLA antibodies. Impact on practice or policy Publication of the study design contributes to harmonization of SARS-CoV-2 vaccine study methodology in kidney patients at high-risk for severe COVID-19. Data on efficacy of SARS-CoV-2 vaccination in patients with CKD will provide guidance for future vaccination policy. [ABSTRACT FROM AUTHOR]

Whether ACE inhibitors (ACEi) differ from other antihypertensives in their efficacy to lower proteinuria is controversial. We therefore performed a meta-analysis of articles on this subject. The secondary objective in our meta-analysis was to study whether there is any difference between diabetic and non-diabetic patients in antiproteinuric response to blood pressure reduction. To identify all articles we performed a computer search using the bibliographic databases. To minimize publication bias, only trials in which a direct comparison was made between an ACEi and another antihypertensive were included. Studies performed both in diabetic and in non-diabetic patients were eligible. Included were 41 studies, comprising 1124 patients, of which 558 had non-diabetic renal disease. The mean antiproteinuric effect of ACEi was significantly greater than that of their comparator drugs: −39.9% (95% confidence interval: −42.8 to −36.8%) versus −17.0% (−19.0 to −15.1%) respectively (difference 24% (19.5 to 28.6%)). The blood-pressure-lowering effect was equal: −12.0% (−12.8 to −11.2%) versus −11.4% (−11.7 to −11.1%) respectively (difference −0.8% (−1.8 to 0.2%)). Thus it may be concluded that ACEIs confer an antiproteinuric effect beyond that attributable to their blood-pressure-lowering effect. A wide interstudy variation in antiproteinuric response to non-ACEI antihypertensives was observed. Multiple variable regression analysis was performed to assess which factors may explain this heterogeneity. From the comparator drugs, the class was of no importance: calcium-channel antagonists (CCA), β-blockers, and a rest group of other drug types showed a similar response. Patient characteristics such as initial GFR and blood pressure partly explained the variation in response, but most of it appeared dependent on the blood pressure reduction achieved. Furthermore the type of CCA is of importance, with nifedipine having the least effect. A significantly greater antiproteinuric effect of ‘non-ACEI’ antihypertensives was found in diabetic patients compared to non-diabetics. However, this coincided with a greater blood pressure reduction in diabetics. Adjusted for differences in blood pressure control, diabetics showed even a slightly lesser antiproteinuric response to non-ACEI antihypertensive compared to non-diabetics. [ABSTRACT FROM PUBLISHER]