Status:
RECRUITING
Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Transplant Genomics, Inc.
Eurofins
Conditions:
Kidney Transplantation
Mycophenolate Mofetil
Eligibility:
All Genders
55+ years
Phase:
PHASE4
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 kid...
Detailed Description
Participation will be two years and it involves blood collection, collection of medical information and images from standard of care kidney biopsies. Subjects will be asked to complete questionnaires ...
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
- Time of Transplant
Key Trial Info
Start Date :
June 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2031
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06568549
Start Date
June 13 2025
End Date
March 31 2031
Last Update
November 12 2025
Active Locations (3)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
3
Mayo Clinic
Rochester, Minnesota, United States, 55905