Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf® Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: t
View:
• 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.
Locations
United States
Arizona
Mayo Clinic
RECRUITING
Phoenix
Florida
Mayo Clinic
RECRUITING
Jacksonville
Minnesota
Mayo Clinic
RECRUITING
Rochester
Contact Information
Primary
Mollie J. Luhman
Luhman.Mollie@mayo.edu
507-266-2812
Backup
Nong Yowe Braaten
Braaten.Nong@mayo.edu
507-266-6893
Time Frame
Start Date: 2025-06-13
Estimated Completion Date: 2031-03-31
Participants
Target number of participants: 350
Treatments
No_intervention: Non-Randomized Group
Individuals who do not meet eligibility for randomization will continue in the study and continue to follow study related visits. Individuals will continue with their current immunosuppression medication.
Active_comparator: MMF Maintenance Group
Individuals randomized to the MMF Maintenance Group will not be withdrawn from their MMF and will continue to follow their standard of care immunosuppression medications.
Experimental: MMF Withdrawal Group
Individuals randomized to the MMF Maintenance Group will be withdrawn from their MMF immunosuppression medication from Month 4 to Month 10 post-transplant.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: Eurofins, Transplant Genomics, Inc.