Status:
ACTIVE_NOT_RECRUITING
Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Immune Kidney Transplant Study (COVID-19)
Lead Sponsor:
Oslo University Hospital
Conditions:
Kidney Transplant Infection
SARS-CoV Infection
Eligibility:
All Genders
18+ years
Brief Summary
None of the vaccines approved, or in clinical trials, have so far been tested on transplanted patients. If they produce an immune response to the Spike protein of SARS-CoV-2 it is unknown how long the...
Detailed Description
Kidney transplanted patients with post-transplant follow-up visits at the national transplant center in Norway will be included before they are SARS-CoV-2 vaccinated. As a control group the investigat...
Eligibility Criteria
Inclusion
- Patients transplanted with a kidney (only) at least 6 months before vaccination OR healthy volunteer first line health care workers at OUS.
- Age of 18 years or older (also for controls).
- Standard immunological risk at transplantation (i.e. no donor specific HLA antibodies (DSA)) and not performed an ABO blood-type-incompatible transplantation.
- No treatment for rejection episodes the last 6 months before inclusion.
- Immunosuppressive therapy including tacrolimus, mycophenolate and prednisolone.
- Stable graft-function the last 6 months.
- S-creatinine \< 200 μmol/L (also for controls).
- Signed informed consent to participate in the study (also for controls).
Exclusion
- Three or more previous transplantations.
- Hemoglobin level below 10 g/dL (also for control).
- Leukopenia defined as total lymphocyte count \< 2 X 109 (also for controls).
- Previous treatment with anti-thymocyte antibodies (ATG) or rituximab.
Key Trial Info
Start Date :
January 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04747522
Start Date
January 22 2021
End Date
December 31 2024
Last Update
April 4 2024
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, 0424