drugset / Trial / NCT05060991

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

NCT05060991

Phase 4 Active not recruiting 14 enrolled University of California, Davis CareDx · collab
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2021-09-24
Primary completion
2026-12-24
Completion
2026-12-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Azathioprine Small molecule
Subject Mycophenolate Mofetil Small molecule
Subject mycophenolic acid Small molecule