Status:
COMPLETED
The REnal Patients COVID-19 VACcination Immune Response (RECOVAC IR) Study
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Erasmus Medical Center
Radboud University Medical Center
Conditions:
Covid19
Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
Brief Summary
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with severely impaired kidney function, on dialysis or alive with a kidney transplant. Therefore, effectiv...
Detailed Description
OBJECTIVES Primary objective: To assess the antibody response after SARS-CoV-2 vaccination in patients with CKD stages 4/5, on dialysis or alive with a kidney transplant as compared to controls. Se...
Eligibility Criteria
Inclusion
- All patients should be eligible for COVID-19 vaccination as described by the instructions of the manufacturer.
- Age of 18 years or older
- Capable of understanding the purpose and risks of the study, fully informed and given written informed consent
- Either
- CKD4/5, with an eGFR \<30 ml/min\*1.73m2 by CKD-EPI
- Hemodialysis, or peritoneal dialysis
- KT recipient at least 6 weeks after transplantation
- Partner, sibling or family member of participating patient
Exclusion
- 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)
- Multi-organ transplant recipients
- Previous or active COVID-19 disease
- Pregnancy or breastfeeding
- Active (haematological) malignancy
- Inherited immune deficiency
- Infection with Human Immunodeficiency Virus (HIV)
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Additional exclusion criterion for patients with CKD stages 4/5, on dialysis and controls:
- \- Individuals who receive maintenance treatment with immunosuppressive therapy in the 6 months before inclusion, including cytotoxic agents or systemic corticosteroids.
- Additional exclusion criterion for controls:
- \- severely impaired kidney function, with an eGFR \< 45 ml/min\*1.73m2 by CKD-EPI
Key Trial Info
Start Date :
February 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 25 2022
Estimated Enrollment :
854 Patients enrolled
Trial Details
Trial ID
NCT04741386
Start Date
February 17 2021
End Date
February 25 2022
Last Update
April 4 2022
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Radboud university medical center
Nijmegen, Gelderland, Netherlands, 6525 GA
2
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands, 1105 AZ
3
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
4
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ