Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf® Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
Mayo Clinic
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.
Description
Participation will be two years and it involves blood collection, collection of medical information and images from standard of care kidney biopsies. Subjects will be asked to complete questionnaires for the study at 12 and 24 months after kidney transplant. The research blood tests that are being collected for the study are called Trugraf®, Eurofins TRAC®, Trac-ID and Immunophenotyping and Single Cell RNA -sequencing. The principal investigator is using this test to see if they can predict and monitor rejection and viral infections in our kidney transplant patients. Immunophenotyping and sing…
Eligibility
- Age range
- 55+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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, belatacep…
Interventions
- DrugMycophenolate 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.
- DrugMycophenolate 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.
Locations (3)
- Mayo ClinicPhoenix, Arizona
- Mayo ClinicJacksonville, Florida
- Mayo ClinicRochester, Minnesota