COVID-19Phase 4ADIVKTNCT05060991
Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients
A Phase 4 study testing Reduction in antimetabolite immunosuppression in people with COVID-19 and Immunosuppression, run by University of California, Davis at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Immunosuppression, Vaccine Response Impaired
- What is being tested?
- Reduction in antimetabolite immunosuppression
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2021to 24 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Contraindication to SARS-CoV-2 vaccination (severe allergic reactions or anaphylaxis)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
Official title: Impact of Immunosuppression Adjustment on the Immune Response to SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients (ADIVKT)
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.
Read the 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.
- Conditions
- COVID-19, Immunosuppression, Vaccine Response Impaired
- Being tested
- Reduction in antimetabolite immunosuppression
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction in antimetabolite immunosuppressionDrug
Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination
| Study group | Role | What they receive |
|---|---|---|
| Immunosuppression reduction | Experimental | Reduction of immunosuppression before and after administration of a third dose of SARS-CoV-2 mRNA vaccine Receives: Drug: Reduction in antimetabolite immunosuppression |
| Standard of care | No intervention | No change to immunosuppression before or after receipt of a third dose of SARS-Co-2 mRNA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anti-SARS-CoV-2 IgG titer to SARS-CoV-2 target proteins from baseline
Measured: 6 weeks after receipt of 3rd dose mRNA vaccine
Percentage of participants who achieve high-positive antibody titer
Measured: 6 weeks after receipt of 3rd dose mRNA vaccine
Secondary outcomes (5)
Acute rejection
Measured: 1 week to 16 weeks after intervention
De Novo donor specific antibody (DSA) development
Measured: 4 week to 16 weeks after intervention
Change in donor-derived cell free DNA from baseline
Measured: 1 week to 16 weeks after intervention
Change in glomerular filtration rate (GFR) from baseline
Measured: 1 week to 16 weeks after intervention
Change in proteinuria from baseline
Measured: 1 week to 16 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start24 Sep 2021
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized open-labeled
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- CareDx
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060991
- Sponsor's protocol ID
- 1801321
- Acronym
- ADIVKT
- Status last verified
- Mar 2026
- First submitted
- 24 Sep 2021
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan SF. Vaccination in kidney disease: what did we learn from COVID-19 pandemic. Curr Opin Nephrol Hypertens. 2023 Sep 1;32(5):412-417. doi: 10.1097/MNH.0000000000000901. Epub 2023 May 23.
PubMed 37382155
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immunosuppression Adjustment on the Immune Response to SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients (ADIVKT)
- ClinicalTrials.gov ID
- NCT05060991
- Acronym / sponsor ID
- ADIVKT / 1801321
- Conditions
- COVID-19, Immunosuppression, Vaccine Response Impaired
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- CareDx
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized open-labeled
| Arm | Type | Receives |
|---|---|---|
| Immunosuppression reduction | Experimental | Drug: Reduction in antimetabolite immunosuppressionReduction of immunosuppression before and after administration of a third dose of SARS-CoV-2 mRNA vaccine |
| Standard of care | No intervention | –No change to immunosuppression before or after receipt of a third dose of SARS-Co-2 mRNA vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Contraindication to SARS-CoV-2 vaccination (severe allergic reactions or anaphylaxis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduction in antimetabolite immunosuppressionReduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination | Drug | Immunosuppression reduction |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Derived from this study: PubMed 37382155Khan SF. Vaccination in kidney disease: what did we learn from COVID-19 pandemic. Curr Opin Nephrol Hypertens. 2023 Sep 1;32(5):412-417. doi: 10.1097/MNH.0000000000000901. Epub 2023 May 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reduction in antimetabolite immunosuppression in people with COVID-19 and Immunosuppression, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05060991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.