Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf® Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
NCT Number: NCT06568549
Acronym: RIOT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Kidney Transplantation|Mycophenolate Mofetil
Interventions: DRUG: Mycophenolate Mofetil (MMF) Maintenance Group|DRUG: Mycophenolate Mofetil (MMF) Withdrawal Group
Sponsor: Mayo Clinic
Collaborators: Transplant Genomics, Inc.|Eurofins
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-03-31
Locations: Mayo Clinic, Rochester, Minnesota, 55905, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Serious Adverse Events (SAE), The total number of subjects to experience SAE's. Defined as subjects experience any one of the following: acute cellular or antibody medicated rejection, borderline rejection or dnDSA (De novo donor-specific antibodies), 1 and 2 years post transplant.|eGFR (estimated glomerular filtration rate), eGFR is calculated from a lab blood test using a formula that measures the level of creatinine. In this test a higher number is better. An eGFR value lower than 60 is a sign that the kidneys may not be working properly. Measured as mL/min/1, 2 years post transplant|Single antigen beads (SAB) for donor-specific antibodies, Single antigen bead (SAB) assay is a lab blood test used to detect human leukocyte antigen antibodies (HLA) and assessing the immunological risk for organ transplant. For HLA-DRβ1/3/4/5 the single molecule mismatches can range from 0-22 and for HLA-DQα1/β1 the single molecule mismatches range from 0-31. Measured as pg/mL., Baseline, 1 year post transplant and 2 years post transplant|BANFF scores, The Banff 2018 classification involves scoring numerous characteristics of renal biopsy specimens. The scores can take values of 0, 1, 2, or 3 for each characteristic, indicating increasing severity of disease as the scores increase., 2 years post transplant.|Absolute lymphocyte counts, An absolute lymphocytes count is determined by multiplying the total number of white blood cells by the percentage of white blood cells that are lymphocytes. The normal range for lymphocytes is between 800 and 5000 (0.8-5.0) lymphocytes per mL of blood. A normal lymphocytes percentage is 18-45% of total white blood cells. Measured as cells per microliter (cells/µL), 1 year post transplant and 2 years post transplant|Transplant Related Symptom (CIRS) Questionnaire, The CIRS questionnaire is a 36-item questionnaire that contains statements that rate transplant symptoms on a scale of 1(None) to 5 (Very Severe). Total scores range from 36-180, lower scores indicate less severe symptoms, higher scores indicate more severe symptoms., 2 years post transplant.|Albumin/Creatinine Ratio (Microalbumin) Urine, The urine albumin-creatinine ratio (uACR) test measures the amount of two different substances in urine - albumin (a protein) and creatinine. A value of 30 or higher suggests a higher risk for kidney failure. Measured as mg/g, 2 years post transplant