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.
To evaluate the feasibility, safety, protocol adherence, biomarker monitoring completion, and preliminary clinical event rates associated with stepwise MMF elimination over 6 months compared with standard-of-care immunosuppression in low-risk older adult kidney transplant recipients. Secondary objectives. To compare between arms: eGFR trajectory and proteinuria at Months 6 and 12; infection incidence (including CMV and BK), hospitalization, and adverse drug events; de novo DSA incidence and time to de novo DSA; and the kinetics and predictive performance of dd-cfDNA and urine CXCL9 and CXCL10 for rejection and de novo DSA. Exploratory objectives. To assess the association between PIRCHE-II score and individual primary endpoint components; the performance of combined biomarker panels versus single biomarkers; health-related quality of life and patient-reported outcomes through Month 12; and cost and healthcare resource utilization through Month 12 across study arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Administration of Tacrolimus
Participants are administered MMF
Participants in SOC arm may be administered Prednisone as indicated
Participants 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
Time frame: 6 months
Protocol Adherence
Proportion of participants completing the assigned treatment strategy without major protocol deviations
Time frame: 6 months
Biomarker Monitoring Completion
Proportion of scheduled biomarker assessments successfully completed.
Time frame: 6 months
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.
Time frame: 6 months
Compare estimated glomerular filtration rate (eGFR) trajectory at Months 6 and 12
Compare estimated glomerular filtration rate (eGFR) trajectory at Months 6 and 12.
Time frame: 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.
Time frame: Months 6 and 12
Comparison of Infection incidence
Number of participants experiencing one or more infections
Time frame: Months 6 and 12
Comparison of Participants Hospitalized
Number of participants experiencing one or more hospitalizations
Time frame: Months 6 and 12
Comparison of Total Hospitalizations
Total number of hospitalizations across all participants
Time frame: Months 6 and 12
Comparison of adverse events
Number of participants experiencing one or more adverse events
Time frame: Months 6 and 12
Comparison of serious adverse events
Number of participants experiencing one or more serious adverse events
Time frame: Months 6 and 12
De Novo Donor-Specific Antibody Incidence
Number of participants who develop confirmed de novo donor-specific antibodies after randomization
Time frame: Month 12
Time to De Novo Donor-Specific Antibody
Time from randomization to first confirmed de novo donor-specific antibody
Time frame: Month12
Donor-Derived Cell-Free DNA (dd-cfDNA)
Longitudinal change in dd-cfDNA and its predictive performance for rejection and de novo donor-specific antibody
Time frame: Month 12
Urine CXCL9 Concentration (pg/mL)
Longitudinal change in urine CXCL9 and its predictive performance for rejection and de novo donor-specific antibody
Time frame: Month 12
Urine CXCL10 Concentration (pg/mL)
Longitudinal change in urine CXCL10 and its predictive performance for rejection and de novo donor-specific antibody
Time frame: Month 12
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