Trial Summary
What is the purpose of this trial?
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.
Research Team
Mark Stegall, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for kidney transplant recipients aged 55 or older. It's not specified who can't join, but typically those with additional serious health issues or incompatible medications would be excluded.Inclusion Criteria
HIV negative
I have not had any organ transplants, but I may have had a stem cell transplant using my own cells.
I am over 55 and have had one or two kidney transplants.
Exclusion Criteria
This criterion does not apply to me as it lacks specific information.
De novo DSA
4-Month Exclusion Criteria:
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Treatment Details
Interventions
- Mycophenolate Mofetil (MMF) (Anti-metabolites)
Trial OverviewThe study is testing the safety and effectiveness of stopping Mycophenolate Mofetil (MMF), a common post-transplant medication, compared to continuing it as standard care in older kidney transplant patients.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: MMF Withdrawal GroupExperimental Treatment1 Intervention
Individuals randomized to the MMF Maintenance Group will be withdrawn from their MMF immunosuppression medication from Month 4 to Month 10 post-transplant.
Group II: MMF Maintenance GroupActive Control1 Intervention
Individuals randomized to the MMF Maintenance Group will not be withdrawn from their MMF and will continue to follow their standard of care immunosuppression medications.
Group III: Non-Randomized GroupActive Control1 Intervention
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Trials
3,427
Recruited
3,221,000+
Dr. Gianrico Farrugia
Mayo Clinic
Chief Executive Officer since 2019
MD from University of Malta Medical School
Dr. Richard Afable
Mayo Clinic
Chief Medical Officer
MD from Loyola Stritch School of Medicine
Transplant Genomics, Inc.
Industry Sponsor
Trials
16
Recruited
4,800+
Eurofins
Industry Sponsor
Trials
20
Recruited
8,100+