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

NCT05060991 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1801321
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Immunosuppression; Vaccine Response Impaired

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Acute rejection

  1 week to 16 weeks after intervention

• De Novo donor specific antibody (DSA) development

  4 week to 16 weeks after intervention

• Change in donor-derived cell free DNA 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 proteinuria from baseline

  1 week to 16 weeks after intervention

Study Arms (2)

Immunosuppression reduction

EXPERIMENTAL

Reduction of immunosuppression before and after administration of a third dose of SARS-CoV-2 mRNA vaccine

Drug: Reduction in antimetabolite immunosuppression

Standard of care

NO INTERVENTION

No change to immunosuppression before or after receipt of a third dose of SARS-Co-2 mRNA vaccine

Interventions

Reduction in antimetabolite immunosuppression DRUG

Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination

Immunosuppression reduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead
• CareDx: collaborator

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

RECRUITING

Related Publications (1)

• Khan SF. Vaccination in kidney disease: what did we learn from COVID-19 pandemic. Curr Opin Nephrol Hypertens. 2023 Sep 1;32(5):412-417. doi: 10.1097/MNH.0000000000000901. Epub 2023 May 23.

  PMID: 37382155 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized open-labeled

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: September 29, 2021
• Study Start: September 24, 2021
• Primary Completion: December 24, 2025
• Study Completion: December 24, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)