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

Study acronym: ADIVKT
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 24, 2025 to Dec 24, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 50 to confirmed 14
    • Site details revised
    v5
  2. Primary completion date: Dec 24, 2024 to Dec 24, 2025
    • Study completion date: Jan 24, 2025 to Dec 24, 2025
    v4
  3. Primary completion date: Dec 24, 2022 to Dec 24, 2024
    • Study completion date: Jan 24, 2023 to Jan 24, 2025
    v3
  4. Primary completion date: Dec 24, 2021 to Dec 24, 2022
    • Study completion date: Sep 24, 2022 to Jan 24, 2023
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05060991
Lead Sponsor University of California, Davis
Collaborators: CareDx
Conditions
(from sponsor)		 COVID-19, Immunosuppression, Vaccine Response Impaired
Related terms COVID-19
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov