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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05060991
Other study ID # 1801321-1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 24, 2021
Est. completion date January 24, 2023

Study information

Verified date February 2022
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 24, 2023
Est. primary completion date December 24, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of California, Davis Sacramento California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Davis CareDx

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Percentage of participants who achieve high-positive antibody titer 6 weeks after receipt of 3rd dose mRNA vaccine
Secondary Acute rejection 1 week to 16 weeks after intervention
Secondary De Novo donor specific antibody (DSA) development 4 week to 16 weeks after intervention
Secondary Change in donor-derived cell free DNA from baseline 1 week to 16 weeks after intervention
Secondary Change in glomerular filtration rate (GFR) from baseline 1 week to 16 weeks after intervention
Secondary Change in proteinuria from baseline 1 week to 16 weeks after intervention
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