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

NCT06568549 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

  • Kidney Transplantation
  • Mycophenolate Mofetil

Interventions

DRUG

Mycophenolate Mofetil (MMF) Maintenance Group

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

DRUG

Mycophenolate Mofetil (MMF) Withdrawal Group

Mycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Withdrawal of MMF immunosuppression medication.

Sponsors & Collaborators

  • Transplant Genomics, Inc.

    collaborator INDUSTRY

  • Eurofins

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Mark D Stegall, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-13
Primary Completion
2030-12-31
Completion
2031-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06568549 on ClinicalTrials.gov