Actively Recruiting
Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf® Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
Led by Mayo Clinic · Updated on 2026-03-20
350
Participants Needed
3
Research Sites
12 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
This research evaluates the safety and effectiveness of reducing the immunosuppressive drug Mycophenolate Mofetil (MMF) in kidney transplant recipients aged 55 years or older. The study compares patients who continue the standard MMF treatment with those who gradually stop taking it. Researchers aim to understand how withdrawing MMF impacts rejection rates, patient survival, and kidney graft function in this older population. Participants are followed for two years, with blood samples collected to perform specialized tests such as Trugraf®, Eurofins TRAC®, Trac-ID, Immunophenotyping, and Single Cell RNA sequencing. These tests help predict and monitor transplant rejection and viral infections. At four months post-transplant, eligible participants without rejection signs or donor-specific antibodies are randomly assigned to either continue MMF, withdraw from MMF gradually between months 4 and 10, or remain in a non-randomized group if they do not qualify for randomization. During the study, participants attend visits at 12 and 24 months to complete questionnaires and have medical information and biopsy images collected. Researchers track outcomes including acute rejection, patient deaths, graft failure, kidney function, antibody presence, symptom questionnaires, and urine tests. The study monitors safety events and collects detailed immune cell data to better understand transplant outcomes over the two-year period.
CONDITIONS
Brief 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 older than 55 years of age with at most one prior solitary kidney transplant.
- No other solid organ transplant recipients; autologous stem cell transplant recipients are eligible.
- HIV negative.
- Currently taking tacrolimus and Mycophenolate Mofetil (MMF) or Myfortic at the time of consent.
- Prednisone use at consent is optional and per local standard of care.
- Eligible patients randomized to MMF withdrawal will start prednisone 5mg daily at 4 months.
- Excludes use of other maintenance immunosuppression medications such as cyclosporine, azathioprine, belatacept, or sirolimus.
You will not qualify if you...
- Donor-specific antibody (DSA) with mean fluorescence intensity (MFI) greater than 2000 at time of transplant.
- Calculated panel reactive antibody (cPRA) above 80% based on MFI greater than 2000 at time of transplant.
- Acute rejection episode greater than borderline (clinical or biopsy) before 4 months post-transplant.
- Any signs of cellular or antibody-mediated rejection at 4-month biopsy.
- Development of de novo donor-specific antibodies.
- Not on tacrolimus at time of randomization.
- History of holding or temporarily discontinuing MMF or Myfortic due to clinical reasons remains eligible.
- Clinically significant acute or chronic medical conditions or physical findings that could compromise well-being or limit study assessments as judged by the investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 4 months to 24 months post-transplant
Participants are randomized at 4 months post-transplant to either continue their current immunosuppression medication or gradually withdraw Mycophenolate Mofetil (MMF). Participants not eligible for randomization continue their current medication regimen.
Study related visits aligned with standard of care follow-up visits over this period
Duration - Up to 24 months post-transplant
Participants complete questionnaires and undergo blood collections and medical assessments at 12 and 24 months post-transplant to monitor transplant outcomes and immune function.
2 visits at 12 and 24 months post-transplant
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
E
Esma Kesik, M.D.
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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