Reduced immunosuppression for older kidney transplant recipients with TruGraf/TRAC monitoring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, multicenter trial enrolls solitary kidney transplant recipients aged 55 and older who are on tacrolimus plus MMF and follows them for two years. At the four-month standard-of-care visit, participants without clinical or biopsy-proven rejection or donor-specific antibodies are randomized to either continue MMF or undergo a gradual MMF withdrawal with prednisone 5 mg/day; those who are ineligible remain in a non-randomized observational group. The study collects clinical data, standard-of-care biopsy images, and blood for TruGraf, Eurofins TRAC, Trac-ID, immunophenotyping, and single-cell RNA sequencing to identify immune signatures and to monitor for rejection and viral infections. Outcomes include safety and efficacy endpoints such as rejection episodes, development of donor-specific antibodies, infection events, and graft function over two years.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Mark D Stegall, M.D. — Mayo Clinic
• Study coordinator: Nong Yowe Braaten, LPN
• Email: braaten.nong@mayo.edu
• Phone: 507-266-6893

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.