Most kidney transplant recipients take a combination of anti-rejection medicines for the rest of their life. One of these is called mycophenolate mofetil (MMF), also known by the brand name CellCept. While MMF helps protect the kidney, taking it for many years can cause infections, low blood counts, stomach problems, and a higher risk of certain cancers, problems that older adults are especially likely to experience.
We are doing this study to learn whether carefully and slowly stopping MMF in older adults who are doing well after their transplant is as safe as continuing MMF, when we use blood and urine tests to closely watch for any early signs of trouble. The information learned could help future kidney transplant patients use less medicine without losing their transplant.
Greater than 60 years of age
Greater than 12 months from kidney transplant
Stable maintenance tacrolimus- based immunosuppression for at least 3 months without dose changes greater than 25%
PIRCHE-II score less than or equal to 65 calculated from available donor and recipient HLA typing
Multi-organ transplant or prior graft loss due to rejection
Maintenance immunosuppression including belatacept, cyclosporine, azathioprine, sirolimus, or other agents in lieu of tacrolimus or MMF
Steroid-free regimen
Active malignancy (excluding non-melanoma skin cancer)
Parallel
Tacrolimus (Kidney transplant maintenance immunosuppression)
DrugAdministration of Tacrolimus
Mycophenoate Mofetil
DrugParticipants are administered MMF
Prednisone (SOC arm)
DrugParticipants in SOC arm may be administered Prednisone as indicated
Prednisone (MMF Elimination arm)
DrugParticipants in the MMF Elimination arm may be administered prednisone as indicated
Feasibility of MMF Elimination
Proportion of eligible participants enrolled and retained through completion of the intervention
Protocol Adherence
Proportion of participants completing the assigned treatment strategy without major protocol deviations
Biomarker Monitoring Completion
Proportion of scheduled biomarker assessments successfully completed.
Clinical Composite Event Rate
Time to first occurrence of all-cause death, graft loss, biopsy-proven rejection, major infection requiring IV therapy or hospitalization, graft-related hospitalization, or confirmed de novo donor-specific antibody.
Compare estimated glomerular filtration rate (eGFR) trajectory at Months 6 and 12
Compare estimated glomerular filtration rate (eGFR) trajectory at Months 6 and 12.
Compare Urine Protein-to-Creatinine Ratio (UPCR) Between Arms at Months 6 and 12
Compare Urine Protein-to-Creatinine Ratio (UPCR) Between Arms at Months 6 and 12.
Comparison of Infection incidence
Number of participants experiencing one or more infections
Comparison of Participants Hospitalized
Number of participants experiencing one or more hospitalizations
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