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

Inclusion Criteria:

• Solitary kidney transplant recipient >55 years of age. At most 1 prior solitarykidney transplant.

• No other solid organ transplant though recipients of autologous stem celltransplants are eligible.

• HIV negative.

• Subjects must be on tacrolimus and mycophenolate mofetil or Myfortic at the time ofconsent. Prednisone at the time of consent is optional and is per local standard ofcare. Patients randomized to MMF withdrawal will be placed on prednisone 5mg/d at 4months. Use of other immunosuppression medications for maintenance (cyclosporine,azathioprine, belatacept, sirolimus) is excluded.

Exclusion Criteria:

Time of Transplant Exclusion Criteria:

• The results of the most recent DSA testing indicate DSA with an MFI >2000.

• The results of the most recent cPRA testing indicate cPRA is above >80% (based onMFI >2000).

4-Month Exclusion Criteria:

• Acute rejection episode either clinical or on biopsy (greater than borderline).Subjects must not experience any type of rejection episodes from the time oftransplant and must not show any signs of rejection (Cellular or Antibody mediatedrejection, excluding borderline) at their 4-month biopsy (If obtained per standardof care). Subjects experiencing rejection will not be eligible for randomization andMMF withdrawal.

• De novo DSA

• Subjects who are not on tacrolimus at the time of randomization will be placed inthe non-randomized group.

• Subjects who at the time of or prior to randomization were maintained onmycophenolate mofetil or Myfortic and have had their medication held or temporarilydiscontinued due to clinical indications (toxicity to the medication, polyoma virusinfections, cancer, etc.) remain eligible for randomization.

• Has a history of an underlying clinically significant acute or chronic medicalcondition or physical examination findings which, in the opinion of theinvestigator, would make study participation not in the participants best interest (e.g., compromise the well-being) or that could prevent, or limit theprotocol-specified assessment.