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Aiming for less medication after kidney transplant: a trial tests a safer path for older adults

NCT ID NCT07806136

Disease control Sponsor: Virginia Commonwealth University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether older adults who had a kidney transplant more than a year ago can safely stop taking mycophenolate mofetil (MMF), a drug that helps prevent rejection but can cause infections, stomach issues, and cancer over time. Researchers will use blood and urine tests to watch for early signs of rejection in participants who slowly stop MMF, comparing them to those who continue standard treatment. The goal is to see if using less medicine can keep the kidney healthy while reducing side effects, which could lead to better long-term care for older transplant recipients.

What this could mean

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

Active substance
Mycophenolate mofetil (MMF) elimination, guided by biomarkers, compared to standard immunosuppression with tacrolimus and possibly prednisone.
What this could lead to
If successful, this approach could allow older kidney transplant patients to take fewer anti-rejection drugs, reducing side effects like infections and cancer risk, while keeping their transplanted kidney healthy.
What could go wrong
This is a small, early-phase pilot study, so results may not apply broadly. Stopping MMF could increase the risk of rejection or graft loss, despite careful monitoring.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

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

60 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: * Greater than 60 years of age * Greater than 12 months from kidney transplant * Stable maintenance tacrolimus- based immunosuppression for at least 3 months without dose changes greater than 25% * PIRCHE-II score less than or equal to 65 calculated from available donor and recipient HLA typing * Ability to provide written informed consent and comply with study procedures Exclusion Criteria: * Multi-organ transplant or prior graft loss due to rejection * Maintenance immunosuppression including belatacept, cyclosporine, azathioprine, sirolimus, or other agents in lieu of tacrolimus or MMF * Steroid-free regimen * Active malignancy (excluding non-melanoma skin cancer) * Uncontrolled infection * BK viremia greater than 10,000 copies/mL, or BK nephropathy * High immunologic risk (any preformed DSA, positive crossmatch, or biopsy-proven rejection within the prior 6 months) * Pregnancy, breastfeeding, self-reported pregnancy, positive pregnancy test during screening if testing is indicated, or inability/unwillingness to comply with required pregnancy prevention measures if of childbearing potential * Inability to comply with study procedures including monthly visits and biospecimen collection * Concurrent participation in another conflicting interventional trial.

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As listed by the trial registrant

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

Kidney transplant recipient

How to take part

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