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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Immunosuppression Vaccine Response Impaired Drug: Reduction in antimetabolite immunosuppression Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized open-labeled
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Immunosuppression Adjustment on the Immune Response to SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients (ADIVKT)
Actual Study Start Date : September 24, 2021
Estimated Primary Completion Date : December 24, 2022
Estimated Study Completion Date : January 24, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Immunosuppression reduction
Reduction of immunosuppression before and after administration of a third dose of SARS-CoV-2 mRNA vaccine
 Drug: Reduction in antimetabolite immunosuppression
Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination
No Intervention: Standard of care
No change to immunosuppression before or after receipt of a third dose of SARS-Co-2 mRNA vaccine


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05060991


Locations
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United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Amanpreet Kaur    916-734-4009    axkaur@ucdavis.edu   
Contact: Katherine Howes       khowes@ucdavis.edu   
Principal Investigator: Aileen X Wang, MD         
Sponsors and Collaborators
University of California, Davis
CareDx
More Information
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Responsible Party: Aileen X Wang, Assistant Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT05060991    
Other Study ID Numbers: 1801321-1
First Posted: September 29, 2021    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antimetabolites
Molecular Mechanisms of Pharmacological Action