ong term efficacy and safety of COVID-19 vaccination in patients with a kidney disease

Phase 1

• Conditions: COVID-19 is associated with increased morbidity and mortality in kidneytransplant recipients (KTR) and patients with chronic kidneydisease(CKD). Therefore, potential efficacious SARS-CoV-2 vaccination would beof great clinical importance in these patients.However, SARS-CoV-2vaccination studies have excluded KTR and patients with CKD so-far and it is unknown how long a possible antibody response will endure.This will be the subject of this trial.; MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862; MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 23.1Level: LLTClassification code 10084508Term: COVID-19 antibody testSystem Organ Class: 100000004848; MedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 100000004862; MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862; MedDRA version: 23.0Level: LLTClassification code 10084462Term: SARS-CoV-2 vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 23.0Level: LLTClassification code 10084463Term: SARS-CoV-2 immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disorders

• Registration Number: EUCTR2021-001520-18-NL
• Lead Sponsor: RECOVAC consortium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-25
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24300

Inclusion Criteria

1.Eligible for COVID-19 vaccination as described by the instructions of the manufacturer.
2.Age of 18 years or older
3.Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
4.Either
-eGFR < 30 ml/min/1.73m2 but not on dialysis or with a kidney transplant
-Hemodialysis, or peritoneal dialysis
-Kidney Transplant recipient at least 6 weeks after transplantation

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4000

Exclusion Criteria

•History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
•Patients who opted out for research in the Santeon, RENINE and NOTR registries.
•Patients who participate in the RECOVAC-IR study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: - To assess the antibody response at 28 days after SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis and in patients after kidney transplantation<br>- To assess durability of the antibody response at 6 months after SARS-CoV 2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis and in patients after kidney transplantation<br>- To assess the safety of vaccination<br>;Main Objective: To assess the efficacy of SARS-CoV vaccination by the incidence of COVID-19 in patients with chronic kidney disease stage G4-G5, on dialysis and patients after kidney transplantation who received SARS-CoV-2 vaccination;Primary end point(s): The incidence of COVID-19 in a two years period after SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.;Timepoint(s) of evaluation of this end point: Two years after SARS-CoV-2 vaccination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Efficacy:<br>oThe antibody based immune response to vaccination against COVID-19 at day 28 after the second vaccination. <br>oThe durability of the antibody response at 6 months after SARS-CoV 2 vaccination<br><br>•Safety: <br>•Incidence of mortality<br>•Incidence of adverse events of specific interest as defined by (inter)national authorities<br>•Incidence of a combined endpoint of acute rejection or graft failure in patients after kidney transplantation <br>•Incidence of HLA antibodies defined as calculated Panel Reactivity Antibodies (cPRA) > 5% in dialysis patients on the waiting list for their first kidney transplantation<br>;Timepoint(s) of evaluation of this end point: Antibody response:<br>28 days and 6 months after vaccination<br>Other endpoints over a period of 2 years