ong term efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation. A prospective observational cohort study by the REnal patients COVID-19 VACcination (RECOVAC) consortium

Phase 4

Completed

Conditions: 10047438
10038430
niertransplantatie, nieraandoeningen zowel in- als exclusief nefropathieën
dialysis
kidney insufficiency
kidney transplantatie

Registration Number: NL-OMON50845

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12000

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

Exclusion Criteria

1. 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).
2.Patients who participate in the RECOVAC-IR study.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The efficacy of SARS-CoV-2 vaccination determined as the incidence of COVID-19<br /><br>after vaccination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety in all patients:<br /><br>• Incidence of mortality<br /><br>• Incidence of adverse events of specific interest as defined by<br /><br>(inter)national authorities in collaboration with LAREB<br /><br>• Incidence of a combined endpoint of acute rejection or graft failure in<br /><br>patients after kidney transplantation<br /><br>• Incidence of HLA antibodies defined as calculated Panel Reactivity Antibodies<br /><br>(cPRA) > 5% in patients on the waiting list for their first kidney<br /><br>transplantation<br /><br><br /><br>Efficacy in a subgroup of patients:<br /><br>• The antibody response against the SARS-CoV-2 Receptor Binding Domain at 28<br /><br>days after the final SARS-CoV-2 vaccination.<br /><br>• The durability of antibody based immune response against SARS-CoV-2 Receptor<br /><br>Binding Domain at 6 months compared to 28 days after completion of SARS-CoV-2<br /><br>vaccination.</p><br>