To assess the efficacy and safety of vaccination against COVID-19 in patients with CKD4/5, patients on dialysis, and kidney transplant recipients as compared to controls
ID
Source
Brief title
Condition
- Other condition
- Renal disorders (excl nephropathies)
Synonym
Health condition
niertransplantatie, nieraandoeningen zowel in- als excl nefropathieen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the antibody based immune response on day 28 after the
second vaccination. Participants will be classified as
responders or non-responders. The definition of response will be based on the
latest available data from the pivotal studies and will be defined prior to
data analyses and the first database lock. We will inform the METC about this
definition and add this information to ClinicalTrials.gov. The percentage of
responders of each patient cohort will be compared with the percentage
responders in the control group.
Secondary outcome
Other secondary endpoints include longevity of the immune response at 6 and 12
months and levels of SARS-CoV-2 specific T and B cell responses. Safety is a
secondary endpoint which will be reported in terms of percentage of solicited
local and systemic adverse events (AEs)graded according to severity.
Background summary
COVID-19 is associated with increased morbidity and mortality in kidney
transplant recipients (KTR) and patients with chronic kidney disease (CKD).
Therefore, potential efficacious SARS-CoV-2 vaccination would be of great
clinical importance in these patients. However, SARS-CoV-2 vaccination studies
have excluded KTR and patients with CKD so-far.
Study objective
To assess the efficacy and safety of vaccination against COVID-19 in patients
with CKD4/5, patients on dialysis, and kidney transplant recipients as compared
to controls
Study design
prospective multicenter multicohort study
Study burden and risks
Patients with kidney disease are hit harder by the COVID-19 pandemic than
healthy individuals. Participation in this study gives early access to
vaccination against COVID-19. For the control group, participation in the trial
helps to protect their partners from getting COVID-19, and gives them early
access to the vaccine. This study will generate highly valuable information on
the ability to mount an effective immune response in this patient group that
can guide management of these patients during the pandemic worldwide.
Participation in this study requires 5 hospital visits at 4 of which blood will
be drawn. Participants have to fill in a questionnaire at baseline. Potentially
eligible subjects who decide not to participate in the study will have access
to the general Dutch vaccination program.
Hanzeplein 1 1
Groningen 9700 RB
NL
Hanzeplein 1 1
Groningen 9700 RB
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-000868-30-NL |
| CCMO | NL76215.042.21 |