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NCT Number: NCT05060991

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Immunosuppression Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccine Response Impaired Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, Davis

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Reduction in antimetabolite immunosuppression

Drug

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

Primary outcomes

  1. Change in anti-SARS-CoV-2 IgG titer to SARS-CoV-2 target proteins from baseline

    Time frame: 6 weeks after receipt of 3rd dose mRNA vaccine

  2. Percentage of participants who achieve high-positive antibody titer

    Time frame: 6 weeks after receipt of 3rd dose mRNA vaccine

Secondary outcomes

  1. Acute rejection

    Time frame: 1 week to 16 weeks after intervention

  2. De Novo donor specific antibody (DSA) development

    Time frame: 4 week to 16 weeks after intervention

  3. Change in donor-derived cell free DNA from baseline

    Time frame: 1 week to 16 weeks after intervention

  4. Change in glomerular filtration rate (GFR) from baseline

    Time frame: 1 week to 16 weeks after intervention

  5. Change in proteinuria from baseline

    Time frame: 1 week to 16 weeks after intervention

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • CareDx

Registry information

Official study title

Impact of Immunosuppression Adjustment on the Immune Response to SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients (ADIVKT)

Acronym: ADIVKT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2021
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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