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 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, 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 on MFI >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 of transplant and must not show any signs of rejection (Cellular or Antibody mediated rejection, excluding borderline) at their 4-month biopsy (If obtained per standard of care). Subjects experiencing rejection will not be eligible for randomization and MMF withdrawal.
• De novo DSA
• Subjects who are not on tacrolimus at the time of randomization will be placed in the non-randomized group.
• Subjects who at the time of or prior to randomization were maintained on mycophenolate mofetil or Myfortic and have had their medication held or temporarily discontinued due to clinical indications (toxicity to the medication, polyoma virus infections, cancer, etc.) remain eligible for randomization.
• 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.