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Reduced Immunosuppression in Older Kidney Transplant Recipients (RIOT Trial)

This study is looking at whether it's safe and effective to reduce or stop a medication called Mycophenolate Mofetil (MMF) in kidney transplant patients aged 55 or older. MMF is a drug that helps prevent your body from rejecting the new kidney. Researchers will compare patients who continue taking MMF (standard care) with those who slowly stop taking it. The goal is to see if reducing MMF can still prevent problems like acute rejection (when your body attacks the new kidney), patient deaths, or graft failure (when the new kidney stops working). You might be able to join if you've had a single kidney transplant, are over 55, and are currently taking tacrolimus and MMF. The study aims to enroll 350 participants, but its current recruitment status is unclear.

Study design
This is a randomized, multicenter study comparing two groups: one that continues Mycophenolate Mofetil (MMF) and one that withdraws MMF. It plans to enroll 350 participants.
What's involved
Participation will last two years and involves blood collections, medical information and images from kidney biopsies, and questionnaires at 12 and 24 months after transplant.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for outcomes like acute rejection, patient deaths, and graft failure between 4 and 24 months post-transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06568549

Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.

Recruiting
PHASE4Ages 55+InterventionalTreatment
Mayo Clinic
~350 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Mycophenolate Mofetil (MMF) Maintenance GroupMycophenolate Mofetil (MMF) Withdrawal Group

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acute Rejection
Measured over 4 to 24 months post transplant.
+2 more outcomes measured

Conditions

Kidney Transplantation
Mycophenolate Mofetil

Explore related trials

Kidney Transplantation

Where it's being run

3 sites across 3 states
Arizona1
Florida1
Minnesota1

Study leadership

  • Mark D Stegall, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Nong Yowe Braaten, LPN
[email protected]
507-266-6893
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).
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.

What this trial measures

  • Acute Rejection4 to 24 months post transplant.

    Total number of subjects to experience acute rejection of the renal transplant

  • Patient Deaths4 to 24 months post transplant.

    Total number of subject deaths from 4-24 months post transplant.

  • Graft Failure4 to 24 months post transplant.

    Total number of subjects to experience graft failure from the renal transplant