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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06568549
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Kidney Transplantation
  • Mycophenolate Mofetil

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Mycophenolate Mofetil (MMF) Maintenance Group — DRUG
    Mycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Maintenance in Immunosuppression medication.
  • Mycophenolate Mofetil (MMF) Withdrawal Group — DRUG
    Mycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Withdrawal of MMF immunosuppression medication.

Study Details

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.

Key Dates

Start date
Jun 13, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Mar 31, 2031

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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    Individuals randomized to the MMF Maintenance Group will not be withdrawn from their MMF and will continue to follow their standard of care immunosuppression medications.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    Individuals randomized to the MMF Maintenance Group will be withdrawn from their MMF immunosuppression medication from Month 4 to Month 10 post-transplant.

Primary Outcome Measure

Acute Rejection [ Time Frame: 4 to 24 months post transplant. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054
Xavier Lopez
[email protected]
480-574-4258
Fady Khorany
[email protected]
480-574-1323
Sami Alasfar, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicJacksonvilleFlorida32224
David A. Legaspi
[email protected]
904-953-4990
Jessica Toukmehji
[email protected]
904-953-8722
Hani M Wadei, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Nong Yowe Braaten, L.P.N.
[email protected]
507-266-6893
Esma Kesik, M.D
[email protected]
507-284-4562
Mark D Stegall, M.D. (PRINCIPAL_INVESTIGATOR)

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