The immune-response and safety of COVID-19 vaccination in patients with chronic kidney disease, on dialysis, or living with a kidney transplant

Phase 4

Completed

Conditions: niertransplantatie, nieraandoeningen zowel in- als excl nefropathieen
dialysis
kidney insufficiency
kidney transplantation
10038430

Registration Number: NL-OMON51071

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 850

Inclusion Criteria

1. All patients should be 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
- CKD4/5, with an eGFR <30 ml/min*1.73m2 by CKD-EPI
- Hemodialysis, or peritoneal dialysis
- Kidney transplant recipient at least 6 weeks after transplantation
- Partner, sibling, or other family member of participating patient with eGFR
> 45 ml/min * 1,73 m2

Exclusion Criteria

-History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) toany component of the study
intervention(s).
-Multi-organ recipients
-Previous or active COVID-19 disease
-Active (haematological) malignancy
-Inherited immune deficiency
-Infection with Human Immunodeficency Virus (HIV)
-Bleeding diathesis or condition associated with prolonged bleeding that would,
in the opinion of the investigator, contraindicate intramuscular injection.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the antibody based immune response on day 28 after the<br /><br>second vaccination. Participants will be classified as<br /><br>responders or non-responders. The definition of response will be based on the<br /><br>latest available data from the pivotal studies and will be defined prior to<br /><br>data analyses and the first database lock. We will inform the METC about this<br /><br>definition and add this information to ClinicalTrials.gov. The percentage of<br /><br>responders of each patient cohort will be compared with the percentage<br /><br>responders in the control group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other secondary endpoints include longevity of the immune response at 6 and 12<br /><br>months and levels of SARS-CoV-2 specific T and B cell responses. Safety is a<br /><br>secondary endpoint which will be reported in terms of percentage of solicited<br /><br>local and systemic adverse events (AEs)graded according to severity.</p><br>