Clinical Trials

Inclusion Criteria: 

Time of Transplant Inclusion Criteria.

• Solitary kidney transplant recipient >55 years of age—first or second transplants.
• No other solid organ transplant though recipients of autologous stem cell transplants are eligible.
• HIV negative.

Time of Transplant Inclusion Criteria.

• Solitary kidney transplant recipient >55 years of age—first or second transplants.
• No other solid organ transplant though recipients of autologous stem cell transplants are eligible.
• HIV negative.

Time of Transplant Exclusion Criteria.

• DSA MFI > 500.
• cPRA> 80% (based on MFI > 2000).
• Prior treatment with MMF or need for MMF therapy (To treat a disease including their primary renal disease).
• 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 be in the participants best. interest (e.g., compromise the well-being) or that could prevent, or limit the protocol-specified assessment.

4-month exclusion criteria (i.e. patients not suitable for MMF withdrawal).

• 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 standard of care biopsy Subjects experiencing rejection will not be eligible for randomization and MMF withdrawal.
• De novo DSA.

Subjects who do not meet the inclusion criteria to move forward with randomization for MMF withdrawal will continue in the study and will follow all standard of care protocol study visits and related procedures, excluding the blood collection of Subject samples obtained for TruGraf® and Viracor TRAC® assays.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/25/2024. Questions regarding updates should be directed to the study team contact.