NCT06568549 Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
| NCT ID | NCT06568549 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mayo Clinic |
| Condition | Kidney Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2025-06-13 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 350 participants in total. It began in 2025-06-13 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Mark D Stegall, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06568549 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Kidney Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06568549 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06568549 currently recruiting?
Yes, NCT06568549 is actively recruiting participants. Contact the research team at braaten.nong@mayo.edu for enrollment information.
Where is the NCT06568549 trial being conducted?
This trial is being conducted at Phoenix, United States, Jacksonville, United States, Rochester, United States.
Who is sponsoring the NCT06568549 clinical trial?
NCT06568549 is sponsored by Mayo Clinic. The principal investigator is Mark D Stegall, M.D. at Mayo Clinic. The trial plans to enroll 350 participants.
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