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Kidney transplant study tests vaccine booster strategy

NCT ID NCT05060991

Knowledge-focused Sponsor: University of California, Davis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether temporarily reducing immunosuppressive medication can help kidney transplant recipients mount a stronger immune response to a third dose of the COVID-19 mRNA vaccine. Fourteen participants with low or no antibodies will have their antimetabolite dose lowered before and after vaccination. The goal is to see if this improves antibody levels while monitoring for organ rejection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
reduction in antimetabolite immunosuppression (mycophenolate mofetil/mycophenolic acid or azathioprine)
What this could lead to
If successful, this could point toward a way to improve vaccine protection for immunocompromised kidney transplant recipients.
What could go wrong
This is a very small early-phase study with only 14 participants, so results may not apply broadly. Lowering immunosuppression carries a risk of organ rejection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

14 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID -19 Immunosuppression Vaccine response impaired

Contacts and locations

Locations

  • University of California, Davis

    Sacramento, California, 95817, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.