A Phase 4 interventional study of Mycophenolate Mofetil (MMF) Maintenance Group and Mycophenolate Mofetil (MMF) Withdrawal Group in Kidney Transplantation and Mycophenolate Mofetil, sponsored by Mayo Clinic. Recruiting at 3 sites in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
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.
Participation will be two years and it involves blood collection, collection of medical information and images from standard of care kidney biopsies. Subjects will be asked to complete questionnaires for the study at 12 and 24 months after kidney transplant. The research blood tests that are being collected for the study are called Trugraf®, Eurofins TRAC®, Trac-ID and Immunophenotyping and Single Cell RNA -sequencing. The principal investigator is using this test to see if they can predict and monitor rejection and viral infections in our kidney transplant patients. Immunophenotyping and single cell RNA sequencing tests are being done to identify unique gene expression profiles and their functions in different immune cells.
At the time of the 4 month standard of care follow up visit, if participants have not experienced any rejection episodes or formed any donor specific antibodies (dnDSA) and are still eligible, randomization will occur. Participants will be put into 1 of 2 groups: Mycophenolate Mofetil Maintenance group where the subject would continue on current medication, or the subject will be placed into the MMF Withdrawal group which means they would slowly be withdrawn from this medication. If the subject is not eligible to be randomized, they will remain in the study and placed into the Non-Randomized group and continue to have study related visits and procedures like the MMF Maintenance group.
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Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Exclusion Criteria:
Time of Transplant Exclusion Criteria:
The results of the most recent cPRA testing indicate cPRA is above >80% (based on MFI >2000).
4-Month Exclusion Criteria:
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.
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.
Drug: Mycophenolate Mofetil (MMF) Maintenance Group
Individuals randomized to the MMF Maintenance Group will be withdrawn from their MMF immunosuppression medication from Month 4 to Month 10 post-transplant.
Drug: Mycophenolate Mofetil (MMF) Withdrawal Group
Mycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Maintenance in Immunosuppression medication.
Also known as: CellCept
Mycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Withdrawal of MMF immunosuppression medication.
Also known as: CellCept
Acute Rejection
Total number of subjects to experience acute rejection of the renal transplant
Time frame: 4 to 24 months post transplant.
Patient Deaths
Total number of subject deaths from 4-24 months post transplant.
Time frame: 4 to 24 months post transplant.
Graft Failure
Total number of subjects to experience graft failure from the renal transplant
Time frame: 4 to 24 months post transplant.
Serious Adverse Events (SAE)
The total number of subjects to experience SAE's. Defined as subjects experience any one of the following: acute cellular or antibody medicated rejection, borderline rejection or dnDSA (De novo donor-specific antibodies)
Time frame: 1 and 2 years post transplant.
eGFR (estimated glomerular filtration rate)
eGFR is calculated from a lab blood test using a formula that measures the level of creatinine. In this test a higher number is better. An eGFR value lower than 60 is a sign that the kidneys may not be working properly. Measured as mL/min/1
Time frame: 2 years post transplant
Single antigen beads (SAB) for donor-specific antibodies
Single antigen bead (SAB) assay is a lab blood test used to detect human leukocyte antigen antibodies (HLA) and assessing the immunological risk for organ transplant. For HLA-DRβ1/3/4/5 the single molecule mismatches can range from 0-22 and for HLA-DQα1/β1 the single molecule mismatches range from 0-31. Measured as pg/mL.
Time frame: Baseline, 1 year post transplant and 2 years post transplant
BANFF scores
The Banff 2018 classification involves scoring numerous characteristics of renal biopsy specimens. The scores can take values of 0, 1, 2, or 3 for each characteristic, indicating increasing severity of disease as the scores increase.
Time frame: 2 years post transplant.
Absolute lymphocyte counts
An absolute lymphocytes count is determined by multiplying the total number of white blood cells by the percentage of white blood cells that are lymphocytes. The normal range for lymphocytes is between 800 and 5000 (0.8-5.0) lymphocytes per mL of blood. A normal lymphocytes percentage is 18-45% of total white blood cells. Measured as cells per microliter (cells/µL)
Time frame: 1 year post transplant and 2 years post transplant
Transplant Related Symptom (CIRS) Questionnaire
The CIRS questionnaire is a 36-item questionnaire that contains statements that rate transplant symptoms on a scale of 1(None) to 5 (Very Severe). Total scores range from 36-180, lower scores indicate less severe symptoms, higher scores indicate more severe symptoms.
Time frame: 2 years post transplant.
Albumin/Creatinine Ratio (Microalbumin) Urine
The urine albumin-creatinine ratio (uACR) test measures the amount of two different substances in urine - albumin (a protein) and creatinine. A value of 30 or higher suggests a higher risk for kidney failure. Measured as mg/g
Time frame: 2 years post transplant
Plan to share: Yes — Plans for data sharing may include data summaries consisting of tables, charts, and figures. Data included will be anonymous and could include demographics, clinical data collected during the study and correlations with Trugraf and Viracor results. Aggregate data for demographics, Subject ID, etc. will only be shared for involving of milestones. The clinical study final report and paper submitted for any publication will also be submitted.
Supporting information: Study protocol, Sap, Icf, Csr
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