At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The RECOVAC LESS CoV-2 Study - Long Term Efficacy and Safety of SARS-CoV-2 Vaccination in Patients in Patients With Chronic Kidney Disease Stage G4-G5, on Dialysis or After Kidney Transplantation
In Brief
An observational study evaluating mailer-based finger-prick for Covid19 and 2 related conditions. Completed, enrolled 4,868 participants across 1 site.
Detailed Summary
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with chronic kidney disease stage G4-G5 and patients on dialysis or after kidney transplantation. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded these patients so-far. Literature data indicate that vaccination may be less effective in these patient groups. Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, patients on dialysis or after kidney transplantation during two years follow-up after vaccination. Study design: prospective single center observational cohort study. Study population: * all Dutch patients on dialysis with data registered in the Dutch Dialysis registry (RENINE) * all Dutch patients after kidney transplantation with data registered in the Dutch national kidney transplant registry (NOTR). * All Dutch patients with chronic kidney disease stage G4-G5 registered in the Santeon hospitals. Intervention: After SARS-CoV-2 vaccination according to standard of care, blood will be drawn for antibody response measurements at day 28 and month 6 after 2nd vaccination at by mailer-based finger-prick in 3400 hemodialysis patients, 600 peritoneal dialysis patients, 4000 patients after kidney transplantation and 4000 patients with chronic kidney disease stage G4-G5. Patients who will undergo a 3rd SARS-CoV-2 vaccination via the national vaccination program for immunocompromised patients will be asked to carry out the mailer-based finger-prick 28 days after the 3rd SARS-CoV-2 vaccination, instead of the antibody measurement 6 months after the 2nd SARS-CoV-2 vaccination. Main study parameters/endpoints: The primary endpoint is efficacy of SARS-CoV-2 vaccination determined as: \- the incidence of COVID-19 after vaccination. Secondary endpoints are * mortality * adverse events of specific interest according to (inter)national authorities in collaboration with LAREB * presence of HLA-antibodies in dialysis patients on the waiting list for a first kidney transplantation * acute rejection and graft failure in patients after kidney transplantation In a subset of patients additional secondary endpoints will be assessed * the antibody based immune response at 28 days after completion of SARS-CoV-2 vaccination. * the durability of antibody based immune response at 6 months compared to at 28 days after having received two subsequent SARS-CoV-2 vaccinations, in patients that have not received a 3rd SARS-CoV-2 vaccine. * the antibody based immune response at 28 days after having received the 3rd SARS-CoV-2 vaccination. The incidence of these endpoints will be compared, if applicable, to those: * in the general population who are vaccinated * in patients on dialysis or after kidney transplant who are not vaccinated Within these patient groups endpoints will be compared between recipients of different vaccines.
Study Details
Timeline
Interventions
All participants in the antibody measurement study will be sent a mailer-based finger-prick set. The sets will be sent to the home address of the patient, including a return envelope. After collecting and returning the samples SARS-CoV-2 antibodies will be analysed quantitatively at the laboratory.