Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
RIOT
1 other identifier
interventional
350
1 country
3
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 kidney transplant. We are comparing them to patients who receive the standard of care Mycophenolate Mofetil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2025
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2024
CompletedFirst Posted
Study publicly available on registry
August 23, 2024
CompletedStudy Start
First participant enrolled
June 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2031
March 20, 2026
March 1, 2026
5.6 years
August 21, 2024
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Acute Rejection
Total number of subjects to experience acute rejection of the renal transplant
4 to 24 months post transplant.
Patient Deaths
Total number of subject deaths from 4-24 months post transplant.
4 to 24 months post transplant.
Graft Failure
Total number of subjects to experience graft failure from the renal transplant
4 to 24 months post transplant.
Secondary Outcomes (7)
Serious Adverse Events (SAE)
1 and 2 years post transplant.
eGFR (estimated glomerular filtration rate)
2 years post transplant
Single antigen beads (SAB) for donor-specific antibodies
Baseline, 1 year post transplant and 2 years post transplant
BANFF scores
2 years post transplant.
Absolute lymphocyte counts
1 year post transplant and 2 years post transplant
- +2 more secondary outcomes
Study Arms (3)
Non-Randomized Group
NO INTERVENTIONIndividuals 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.
MMF Maintenance Group
ACTIVE COMPARATORIndividuals randomized to the MMF Maintenance Group will not be withdrawn from their MMF and will continue to follow their standard of care immunosuppression medications.
MMF Withdrawal Group
EXPERIMENTALIndividuals randomized to the MMF Maintenance Group will be withdrawn from their MMF immunosuppression medication from Month 4 to Month 10 post-transplant.
Interventions
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), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Withdrawal of MMF immunosuppression medication.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- The results of the most recent DSA testing indicate DSA with an MFI \>2000.
- The results of the most recent cPRA testing indicate cPRA is above \>80% (based on MFI \>2000).
- Acute rejection episode either clinical or on biopsy (greater than borderline). Subjects must not experience any type of rejection episodes from the time of transplant and must not show any signs of rejection (Cellular or Antibody mediated rejection, excluding borderline) at their 4-month biopsy (If obtained per standard of care). Subjects experiencing rejection will not be eligible for randomization and MMF withdrawal.
- De novo DSA
- Subjects who are not on tacrolimus at the time of randomization will be placed in the non-randomized group.
- Subjects who at the time of or prior to randomization were maintained on mycophenolate mofetil or Myfortic and have had their medication held or temporarily discontinued due to clinical indications (toxicity to the medication, polyoma virus infections, cancer, etc.) remain eligible for randomization.
- Has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings which, in the opinion of the investigator, would make study participation not in the participants best interest (e.g., compromise the well-being) or that could prevent, or limit the protocol-specified assessment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Transplant Genomics, Inc.collaborator
- Eurofinscollaborator
Study Sites (3)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark D Stegall, M.D.
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 21, 2024
First Posted
August 23, 2024
Study Start
June 13, 2025
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
March 31, 2031
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Ongoing data analysis will be performed throughout the study. After completion of all study subjects' visits, final data will be cleaned, reviewed and analyzed by study staff. A clinical summary report would be expected to be delivered to TGI-Eurofins within a year of subject completed visits. We would expect a paper to be written and submitted to a journal for review and acceptance within 2 years of final study completion.
- Access Criteria
- Data sharing with TGI- Eurofins and study staff.
Plans for data sharing may include data summaries consisting of tables, charts, and figures. Data included will be anonymous and could include demographics, clinical data collected during the study and correlations with Trugraf and Viracor results. Aggregate data for demographics, Subject ID, etc. will only be shared for involving of milestones. The clinical study final report and paper submitted for any publication will also be submitted.