A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients

1044220

Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related toxicities. Therefore, the investigators hypothesize that by transitioning patients from tacrolimus immediate release to Envarsus ®, the peak-dose effect will be eliminated or attenuated, leading to a significant decrease in neurocognitive toxicities in the older patient population.

2018-04-01

2022-12-31

2023-07-31

Completed

Early phase I

64

Inclusion Criteria: 1. Recipient of a kidney transplant 2. Age 60 or greater at the time of transplant 3. Kidney graft is functional (not dialysis dependent) by 4 weeks post-transplant 4. Have IR tacrolimus as maintenance therapy 5. Have BMI \< 35 at time of transplant 6. Achieve therapeutic tacrolimus level within 4 weeks post-transplant Exclusion Criteria: 1. Recipient of a simultaneous non-kidney transplant (pancreas) 2. Had an episode of rejection before study enrollment 3. Had a TIA/CVA after transplantation and before study enrollment 4. Had a neurologic injury after transplantation and before study enrollment 5. Blindness 6. Have an mTOR inhibitor as maintenance therapy 7. Nonadherence, as determined by a trough level less than 7 ng/mL after achieving therapeutic level with no other rationale for sub-therapeutic levels. 8. Adults unable to consent 9. Pregnant women 10. Prisoners

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 64, 'type': 'ACTUAL'}}

2023-12-05