Clinical Trial

Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients

Study acronym: ADIVKT

Active, Not Recruiting Phase 4

Summary

Immunocompromised individuals, such as solid organ transplant (SOT) recipients are at high risk of COVID-19 associated complications and mortality. Retrospective studies so far have shown that a majority of SOT recipients did not develop appreciable anti-spike antibody response after a first, second, or even third dose of mRNA vaccine. Treatment with antimetabolites was associated with poor vaccine response. The goal of this study is 1) examine whether transient immunosuppression reduction improves the immune response to a third dose of SARS-CoV-2 mRNA vaccine in kidney transplant recipients and 2) to assess the safety of immunosuppression reduction before and after third dose SARS-CoV-2 mRNA vaccination.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2021-09-27; most recent amendment 2026-03-30.

Status change: Recruiting → Active, Not Recruiting 2026-03-30

Trial Details

NCT Number	NCT05060991
Lead Sponsor	University of California, Davis Collaborators: CareDx
Conditions	COVID-19, Immunosuppression, Vaccine Response Impaired
Enrollment	14 participants
Start Date	2021-09-24
Primary Completion	2026-12-24 (estimated)
Study Completion	2026-12-24 (estimated)
Updated on ClinicalTrials.gov	2026-04-03