Who is eligible for clinical trial NCT06568549?

Participants must meet the protocol's inclusion criteria for Kidney Transplantation. The stated age range is 55 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06568549 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-18

Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial. (NCT06568549)

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

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Mayo Clinic

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (8 items).

Location: Mayo Clinic — Phoenix, Arizona

Age range: 55 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

Mayo Clinic — Phoenix, Arizona
Mayo Clinic — Jacksonville, Florida
Mayo Clinic — Rochester, Minnesota

📞 Contact the Study Coordinator

Phone: (507) 266-6893

Email: braaten.nong@mayo.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Kidney Transplantation

REgulatory T Cell Therapy to Achieve Immunosuppression REduction — Phoenix, Arizona
Envarsus XR® in Adolescent Renal Transplant Recipients — Los Angeles, California
Prehabilitation for Kidney Transplant Candidates — Houston, Texas
The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients — Pittsburgh, Pennsylvania
Watermelon/UBIQuinone Study — San Francisco, California

Explore by condition: All Kidney Transplantation clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗