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.
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.
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).
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
Parallel
Mycophenolate Mofetil (MMF) Maintenance Group
DrugMycophenolate 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
DrugMycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Withdrawal of MMF immunosuppression medication.
Acute Rejection
Total number of subjects to experience acute rejection of the renal transplant
Patient Deaths
Total number of subject deaths from 4-24 months post transplant.
Graft Failure
Total number of subjects to experience graft failure from the renal 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)
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
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.
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.
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