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

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ClinicalTrials.gov Identifier: NCT05060991
Recruitment Status : Recruiting
First Posted : September 29, 2021
Last Update Posted : February 8, 2022
Sponsor:
Collaborator:
CareDx
Information provided by (Responsible Party):
Aileen X Wang, University of California, Davis

Tracking Information
First Submitted Date  ICMJE September 24, 2021
First Posted Date  ICMJE September 29, 2021
Last Update Posted Date February 8, 2022
Actual Study Start Date  ICMJE September 24, 2021
Estimated Primary Completion Date December 24, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2021)
  • 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 ]
  • Percentage of participants who achieve high-positive antibody titer [ Time Frame: 6 weeks after receipt of 3rd dose mRNA vaccine ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2021)
  • Acute rejection [ Time Frame: 1 week to 16 weeks after intervention ]
  • De Novo donor specific antibody (DSA) development [ Time Frame: 4 week to 16 weeks after intervention ]
  • Change in donor-derived cell free DNA from baseline [ Time Frame: 1 week to 16 weeks after intervention ]
  • Change in glomerular filtration rate (GFR) from baseline [ Time Frame: 1 week to 16 weeks after intervention ]
  • Change in proteinuria from baseline [ Time Frame: 1 week to 16 weeks after intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients
Official Title  ICMJE Impact of Immunosuppression Adjustment on the Immune Response to SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients (ADIVKT)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective randomized open-labeled
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • COVID-19
  • Immunosuppression
  • Vaccine Response Impaired
Intervention  ICMJE Drug: Reduction in antimetabolite immunosuppression
Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination
Study Arms  ICMJE
  • Experimental: Immunosuppression reduction
    Reduction of immunosuppression before and after administration of a third dose of SARS-CoV-2 mRNA vaccine
    Intervention: Drug: Reduction in antimetabolite immunosuppression
  • No Intervention: Standard of care
    No change to immunosuppression before or after receipt of a third dose of SARS-Co-2 mRNA vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2021)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 24, 2023
Estimated Primary Completion Date December 24, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05060991
Other Study ID Numbers  ICMJE 1801321-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Aileen X Wang, University of California, Davis
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, Davis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE CareDx
Investigators  ICMJE Not Provided
PRS Account University of California, Davis
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP