To assess the efficacy of SARS-CoV-2 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
ID
Source
Brief title
Condition
- Other condition
- Viral infectious disorders
- Renal disorders (excl nephropathies)
Synonym
Health condition
niertransplantatie, nieraandoeningen zowel in- als exclusief nefropathieën
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The efficacy of SARS-CoV-2 vaccination determined as the incidence of COVID-19
after vaccination.
Secondary outcome
Safety in all patients:
• Incidence of mortality
• Incidence of adverse events of specific interest as defined by
(inter)national authorities in collaboration with LAREB
• Incidence of a combined endpoint of acute rejection or graft failure in
patients after kidney transplantation
• Incidence of HLA antibodies defined as calculated Panel Reactivity Antibodies
(cPRA) > 5% in patients on the waiting list for their first kidney
transplantation
Efficacy in a subgroup of patients:
• The antibody response against the SARS-CoV-2 Receptor Binding Domain at 28
days after the final SARS-CoV-2 vaccination.
• The durability of antibody based immune response against SARS-CoV-2 Receptor
Binding Domain at 6 months compared to 28 days after completion of SARS-CoV-2
vaccination.
Background summary
COVID-19 is associated with severely increased morbidity and mortality in
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 patients on kidney
replacement therapy so-far. Literature data indicate that vaccination may be
less effective in these patient groups.
Study objective
To assess the efficacy of SARS-CoV-2 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
Study design
Prospective observational cohort study.
Study burden and risks
Study related procedures will be limited to blood withdrawals via a
mailer-based finger prick (in total a maximum of 1 mL). Risks
associated with participation in this study will therefore be minimal. Patients
will be vaccinated according to routine clinical practice, wheter or not they
are participating in this study and all vaccinated patients are eligible for
participation in the trial.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
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.
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 | EUCTR2021-001520-18-NL |
| CCMO | NL76839.042.21 |
| Other | volgt |