Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
NCT ID: NCT06568549
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
350 participants
INTERVENTIONAL
2025-06-13
2031-03-31
Brief Summary
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Detailed Description
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At the time of the 4 month standard of care kidney biopsy, if participants have not experienced any rejection episodes or formed any donor specific antibodies (dnDSA) and are still eligible, randomization will occur. Participants will be put into 1 of 2 groups: Mycophenolate Mofetil Maintenance group where the subject would continue on current medication, or the subject will be placed into the MMF Withdrawal group which means they would slowly be withdrawn from this medication. If the subject is not eligible to be randomized, they will remain in the study and placed into the Non-Randomized group and continue to have study related visits and procedures like the MMF Maintenance group.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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Individuals randomized to the MMF Maintenance Group will not be withdrawn from their MMF and will continue to follow their standard of care immunosuppression medications.
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.
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Individuals randomized to the MMF Maintenance Group will be withdrawn from their MMF immunosuppression medication from Month 4 to Month 10 post-transplant.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* The results of the most recent cPRA testing indicate cPRA is above \>80% (based on MFI \>2000).
* 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. compromises their well-being) or that could prevent, or limit the protocol specified assessment.
* 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 standard of care biopsy Subjects experiencing rejection will not be eligible for randomization and MMF withdrawal.
* Subjects who are unable to undergo their 4-month standard of care kidney biopsy due to medical contraindications.
* De novo DSA
* Subjects who are not maintained on tacrolimus, mycophenolate mofetil of Myfortic. Subjects who are not on tacrolimus and mycophenolate mofetil or Myfortic at the time of randomization will be placed in the non-randomized group.
* 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.
55 Years
ALL
Yes
Sponsors
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Transplant Genomics, Inc.
INDUSTRY
Eurofins
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Mark Stegall
Principal Investigator
Principal Investigators
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Mark D Stegall, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Xavier Lopez
Role: primary
Fady Khorany
Role: backup
David A. Legaspi
Role: primary
Jessica Toukmehji
Role: backup
Mollie J Luhman
Role: primary
Nong Yowe Braaten
Role: backup
Other Identifiers
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24-002574
Identifier Type: -
Identifier Source: org_study_id