Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf® Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
- Conditions
- Kidney TransplantationMycophenolate Mofetil
- Registration Number
- NCT06568549
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria:<br><br> - Solitary kidney transplant recipient >55 years of age-first or second transplants.<br><br> - No other solid organ transplant though recipients of autologous stem cell<br> transplants are eligible.<br><br> - HIV negative.<br><br>Exclusion Criteria:<br><br>Time of Transplant Exclusion Criteria:<br><br> - DSA MFI >500<br><br> - cPRA >80% (based on MFI .2000)<br><br> - Prior treatment with MMF or need for MMF therapy (To treat a disease including their<br> primary disease).<br><br> - Has a history of an underlying clinically significant acute or chronic medical<br> condition or physical examination findings which, in the opinion of the<br> investigator, would make study participation not in the participants best interest<br> (e.g. compromises their well-being) or that could prevent, or limit the protocol<br> specified assessment.<br><br> 4-Month Exclusion Criteria:<br><br> - Acute rejection episode either clinical or on biopsy (greater than borderline).<br> Subjects must not experience any type of rejection episodes from the time of<br> transplant and must not show any signs of rejection (Cellular or Antibody mediated<br> rejection, excluding borderline) at their 4-month standard of care biopsy Subjects<br> experiencing rejection will not be eligible for randomization and MMF withdrawal.<br><br> - De novo DSA<br><br> - Has a history of an underlying clinically significant acute or chronic medical<br> condition or physical examination findings which, in the opinion of the<br> investigator, would make study participation not in the participants best interest<br> (e.g., compromise the well-being) or that could prevent, or limit the<br> protocol-specified assessment.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acute Rejection;Patient Deaths;Graft Failure
- Secondary Outcome Measures
Name Time Method Serious Adverse Events (SAE);eGFR (estimated glomerular filtration rate);Single antigen beads (SAB) for donor-specific antibodies;BANFF scores;Absolute lymphocyte counts;Transplant Related Symptom (CIRS) Questionnaire;Albumin/Creatinine Ratio (Microalbumin) Urine