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

Phase 4

Recruiting

• Conditions: COVID-19; Immunosuppression; Vaccine Response Impaired
• Interventions: Drug: Reduction in antimetabolite immunosuppression

• Registration Number: NCT05060991
• Lead Sponsor: University of California, Davis

Brief 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.

Detailed Description

This is a prospective, randomized open-labeled study of kidney transplant recipients who have previously received two doses of mRNA COVID-19 vaccine (either BNT162b2, Pfizer-BioNTech or mRNA-1273, Moderna) and who are eligible to receive a 3rd dose of mRNA vaccine.

Study Timeline

• Study Start: 2021-09-24
• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-09-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-12-24
• Study Completion: 2025-12-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study
• First or repeat kidney transplant recipient
• Negative or low positive antibody titer on SARS-CoV-2 antibody assay
• On a mycophenolate or azathioprine based immunosuppressive regimen
• > 6 months post-transplant

Exclusion Criteria

• Pregnancy
• Contraindication to SARS-CoV-2 vaccination (severe allergic reactions or anaphylaxis)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immunosuppression reduction	Reduction in antimetabolite immunosuppression	Reduction of immunosuppression before and after administration of a third dose of SARS-CoV-2 mRNA vaccine

Primary Outcome Measures

Name	Time	Method
Change in anti-SARS-CoV-2 IgG titer to SARS-CoV-2 target proteins from baseline	6 weeks after receipt of 3rd dose mRNA vaccine
Percentage of participants who achieve high-positive antibody titer	6 weeks after receipt of 3rd dose mRNA vaccine

Secondary Outcome Measures

Name	Time	Method
De Novo donor specific antibody (DSA) development	4 week to 16 weeks after intervention
Acute rejection	1 week to 16 weeks after intervention
Change in proteinuria from baseline	1 week to 16 weeks after intervention
Change in glomerular filtration rate (GFR) from baseline	1 week to 16 weeks after intervention
Change in donor-derived cell free DNA from baseline	1 week to 16 weeks after intervention

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Sacramento, California, United States