NCT06568549 · Mayo Clinic
Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
(RIOT)
What this study is about
The purpose of this research is to determine the safety and effectiveness of withdrawing MMF (Mycophenolate Mofetil) in kidney transplant recipients who are 55 years or older at the time of receiving a kidney transplant. We are comparing them to patients who receive the the usual treatment Mycophenolate Mofetil.
View original scientific description
The purpose of this research is to determine the safety and efficacy of withdrawing MMF (Mycophenolate Mofetil) in kidney transplant recipients who are 55 years or older at the time of receiving a kidney transplant. We are comparing them to patients who receive the standard of care Mycophenolate Mofetil.
Interventions
DRUG
Mycophenolate Mofetil (MMF) Maintenance Group
Mycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Maintenance in Immunosuppression medication.
DRUG
Mycophenolate Mofetil (MMF) Withdrawal Group
Mycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Withdrawal of MMF immunosuppression medication.
Primary outcome measures
Acute Rejection
Time frame: 4 to 24 months post transplant.
Total number of subjects to experience acute rejection of the renal transplant
Patient Deaths
Time frame: 4 to 24 months post transplant.
Total number of subject deaths from 4-24 months post transplant.
Graft Failure
Time frame: 4 to 24 months post transplant.
Total number of subjects to experience graft failure from the renal transplant
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
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).
- 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. compromises their well-being) or that could prevent, or limit the protocol specified assessment. 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
Where
- Phoenix, Arizona
- Jacksonville, Florida
- Rochester, Minnesota
Collaborators
Transplant Genomics, Inc., Eurofins
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 20, 2026 · Source of record for eligibility and locations