Recruiting

MMF vs. Standard Care

Sponsor:

Mayo Clinic

Code:

NCT06568549

Conditions

Kidney Transplantation

Mycophenolate Mofetil

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

Mycophenolate Mofetil (MMF) Maintenance Group

Mycophenolate Mofetil (MMF) Withdrawal Group

Study Details

Brief summary:

The purpose of this research is to determine the safety and efficacy of withdrawing MMF (Mycophenolate Mofetil) in kidney transplant recipients who are 55 years or older at the time of receiving a kidney transplant. We are comparing them to patients who receive the standard of care Mycophenolate Mofetil.

Conditions

Kidney Transplantation

Mycophenolate Mofetil

Study ID

NCT06568549

Start date

Jun 13, 2025

Status verified date

Mar, 2026

Completion date

Mar 31, 2031

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Non-Randomized Group

Individuals who do not meet eligibility for randomization will continue in the study and continue to follow study related visits. Individuals will continue with their current immunosuppression medication.

active comparator: MMF Maintenance Group

Individuals randomized to the MMF Maintenance Group will not be withdrawn from their MMF and will continue to follow their standard of care immunosuppression medications.

experimental: MMF Withdrawal Group

Individuals randomized to the MMF Maintenance Group will be withdrawn from their MMF immunosuppression medication from Month 4 to Month 10 post-transplant.

Interventions

Mycophenolate Mofetil (MMF) Maintenance Group

Mycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Maintenance in Immunosuppression medication.

Mycophenolate Mofetil (MMF) Withdrawal Group

Mycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Withdrawal of MMF immunosuppression medication.

Primary outcome measure

  • Acute Rejection [ Time Frame: 4 to 24 months post transplant. ]
  • Patient Deaths [ Time Frame: 4 to 24 months post transplant. ]
  • Graft Failure [ Time Frame: 4 to 24 months post transplant. ]

Central Contacts and Locations

Central contacts

Nong Yowe Braaten, LPN

507-266-6893braaten.nong@mayo.edu

Esma Kesik, M.D.

507-284-4562kesik.esma@mayo.edu

Locations

Mayo Clinic

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Xavier Lopez

480-574-4258lopez.xavier@mayo.edu

Fady Khorany

480-574-1323khorany.fady@mayo.edu

Principal Investigator:

Sami Alasfar, MD

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

David A. Legaspi

904-953-4990legaspi.david@mayo.edu

Jessica Toukmehji

904-953-8722toukmehji.jessica@mayo.edu

Principal Investigator:

Hani M Wadei, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Nong Yowe Braaten, L.P.N.

507-266-6893braaten.nong@mayo.edu

Esma Kesik, M.D

507-284-4562kesik.esma@mayo.edu

Principal Investigator:

Mark D Stegall, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • Kidney Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-20.