Reduced immunosuppression for older kidney transplant recipients with TruGraf/TRAC monitoring
Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf® Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
This study will see if stopping mycophenolate mofetil (MMF) in kidney transplant patients aged 55 and older, while using TruGraf/TRAC blood tests to watch for rejection and infections, is as safe as continuing the medication.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 3 sites (Phoenix, Arizona and 2 other locations) |
| Trial ID | NCT06568549 on ClinicalTrials.gov |
What this trial studies
This randomized, multicenter trial enrolls solitary kidney transplant recipients aged 55 and older who are on tacrolimus plus MMF and follows them for two years. At the four-month standard-of-care visit, participants without clinical or biopsy-proven rejection or donor-specific antibodies are randomized to either continue MMF or undergo a gradual MMF withdrawal with prednisone 5 mg/day; those who are ineligible remain in a non-randomized observational group. The study collects clinical data, standard-of-care biopsy images, and blood for TruGraf, Eurofins TRAC, Trac-ID, immunophenotyping, and single-cell RNA sequencing to identify immune signatures and to monitor for rejection and viral infections. Outcomes include safety and efficacy endpoints such as rejection episodes, development of donor-specific antibodies, infection events, and graft function over two years.
Who should consider this trial
Good fit: Ideal candidates are solitary kidney transplant recipients aged 55 or older who are on tacrolimus plus MMF, have had no rejection or donor-specific antibodies by four months, and meet the trial's DSA (MFI ≤2000) and cPRA (≤80%) thresholds.
Not a fit: Patients with recent or biopsy-proven rejection, high immunologic risk (DSA MFI >2000 or cPRA >80%), recipients of other maintenance immunosuppressants, multiple organ transplant recipients, or HIV-positive individuals are unlikely to benefit from MMF withdrawal under this protocol.
Why it matters
Potential benefit: If successful, some older kidney transplant recipients might stop MMF and experience fewer infections and medication-related side effects while preserving graft health.
How similar studies have performed: Immunosuppression minimization has been attempted before with mixed results, and biomarker-guided MMF withdrawal using TruGraf/TRAC is relatively novel with limited large randomized evidence so far.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Phoenix, Arizona and 2 other locations
- Mayo Clinic — Phoenix, Arizona, United States (Recruiting)
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Mark D Stegall, M.D. — Mayo Clinic
- Study coordinator: Nong Yowe Braaten, LPN
- Email: braaten.nong@mayo.edu
- Phone: 507-266-6893
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.