Could older kidney patients take fewer drugs? new trial aims to find out
NCT ID NCT06568549
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether older kidney transplant patients (55 and up) can safely stop taking one of their standard immunosuppressant drugs, mycophenolate mofetil (MMF). About 350 participants will be randomly assigned to either continue MMF or stop it, while staying on other medications. The goal is to see if reducing drugs lowers side effects without increasing the risk of kidney rejection or failure.
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, also known as CellCept)
- What this could lead to
- If successful, this could show that older kidney transplant patients can safely take fewer immunosuppressant drugs, reducing side effects like infections and other complications.
- What could go wrong
- This is a Phase 4 trial, so the drugs are already approved, but withdrawing MMF may increase the risk of kidney rejection or graft failure. Results may not apply to younger patients or those with other transplants.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 350 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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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
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55 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Solitary kidney transplant recipient \>55 years of age. At most 1 prior solitary kidney transplant. * No other solid organ transplant though recipients of autologous stem cell transplants are eligible. * HIV negative. * Subjects must be on tacrolimus and mycophenolate mofetil or Myfortic at the time of consent. Prednisone at the time of consent is optional and is per local standard of care. Patients randomized to MMF withdrawal will be placed on prednisone 5mg/d at 4 months. Use of other immunosuppression medications for maintenance (cyclosporine, azathioprine, belatacept, sirolimus) is excluded. Exclusion Criteria: Time of Transplant Exclusion Criteria: * The results of the most recent DSA testing indicate DSA with an MFI \>2000. * The results of the most recent cPRA testing indicate cPRA is above \>80% (based on MFI \>2000). 4-Month Exclusion Criteria: * Acute rejection episode either clinical or on biopsy (greater than borderline). Subjects must not experience any type of rejection episodes from the time of transplant and must not show any signs of rejection (Cellular or Antibody mediated rejection, excluding borderline) at their 4-month biopsy (If obtained per standard of care). Subjects experiencing rejection will not be eligible for randomization and MMF withdrawal. * De novo DSA * Subjects who are not on tacrolimus at the time of randomization will be placed in the non-randomized group. * Subjects who at the time of or prior to randomization were maintained on mycophenolate mofetil or Myfortic and have had their medication held or temporarily discontinued due to clinical indications (toxicity to the medication, polyoma virus infections, cancer, etc.) remain eligible for randomization. * Has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings which, in the opinion of the investigator, would make study participation not in the participants best interest (e.g., compromise the well-being) or that could prevent, or limit the protocol-specified assessment.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic
RECRUITINGPhoenix, Arizona, 85054, United States
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Mayo Clinic
RECRUITINGJacksonville, Florida, 32224, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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