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

Primary Purpose

COVID-19, Immunosuppression, Vaccine Response Impaired

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Reduction in antimetabolite immunosuppression

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of California, DavisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immunosuppression reduction

Standard of care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Percentage of participants who achieve high-positive antibody titer

Secondary Outcome Measures

Acute rejection

De Novo donor specific antibody (DSA) development

Change in donor-derived cell free DNA from baseline

Change in glomerular filtration rate (GFR) from baseline

Change in proteinuria from baseline

Full Information

NCT ID

NCT05060991

First Posted

September 24, 2021

Last Updated

February 7, 2022

Sponsor

University of California, Davis

Collaborators

CareDx

1. Study Identification

Unique Protocol Identification Number

NCT05060991

Brief Title

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

Acronym

ADIVKT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 24, 2021 (Actual)

Primary Completion Date

December 24, 2022 (Anticipated)

Study Completion Date

January 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Davis

Collaborators

CareDx

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Immunosuppression, Vaccine Response Impaired

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Prospective randomized open-labeled

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immunosuppression reduction

Arm Type

Experimental

Arm Description

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

Arm Title

Standard of care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Reduction in antimetabolite immunosuppression

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

Percentage of participants who achieve high-positive antibody titer

Time Frame

6 weeks after receipt of 3rd dose mRNA vaccine

Secondary Outcome Measure Information:

Title

Acute rejection

Time Frame

1 week to 16 weeks after intervention

Title

De Novo donor specific antibody (DSA) development

Time Frame

4 week to 16 weeks after intervention

Title

Change in donor-derived cell free DNA from baseline

Time Frame

1 week to 16 weeks after intervention

Title

Change in glomerular filtration rate (GFR) from baseline

Time Frame

1 week to 16 weeks after intervention

Title

Change in proteinuria from baseline

Time Frame

1 week to 16 weeks after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Facility Information:

Facility Name

University of California, Davis

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amanpreet Kaur

Phone

916-734-4009

axkaur@ucdavis.edu

First Name & Middle Initial & Last Name & Degree

Katherine Howes

khowes@ucdavis.edu

First Name & Middle Initial & Last Name & Degree

Aileen X Wang, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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