Actively Recruiting
Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
Led by Mayo Clinic · Updated on 2026-03-20
350
Participants Needed
3
Research Sites
302 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
T
Transplant Genomics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Solitary kidney transplant recipient aged over 55 years, with at most one prior solitary kidney transplant
- No other solid organ transplant; autologous stem cell transplant recipients are allowed
- HIV negative
- Currently on tacrolimus and Mycophenolate Mofetil (MMF) or Myfortic at consent; prednisone use optional per local care
- Patients randomized to MMF withdrawal will start prednisone 5mg/day at 4 months
- Use of other maintenance immunosuppressants (cyclosporine, azathioprine, belatacept, sirolimus) is not allowed
You will not qualify if you...
- Donor-specific antibody (DSA) with MFI greater than 2000 at time of transplant
- Calculated panel reactive antibody (cPRA) above 80% (based on MFI >2000) at time of transplant
- Acute rejection episode (greater than borderline) at any time before 4 months or signs of rejection at 4-month biopsy
- Presence of de novo DSA
- Not on tacrolimus at time of randomization (placed in non-randomized group)
- History of holding or temporarily stopping MMF or Myfortic due to clinical reasons does not exclude randomization
- Any clinically significant acute or chronic medical condition or physical exam finding making participation unsafe or limiting assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
N
Nong Yowe Braaten, LPN
CONTACT
E
Esma Kesik, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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