Study of Neurocognitive Changes With Once-Daily Extended-Release Tacrolimus Compared to Twice-Daily Immediate-Release Tacrolimus in Older Kidney Transplant Patients

What this Trial Is About

Researchers are evaluating the neurocognitive outcomes in older kidney transplant recipients using two forms of tacrolimus immediate-release IR tacrolimus Prograf and extended-release tacrolimus Envarsus XR. The study aims to compare changes in brain function between those who continue taking IR tacrolimus and those who switch to the extended-release version. This trial is a randomized controlled Phase 4 study focused on patients aged 65 and older who have received a kidney transplant at least one year ago. Participants will be randomly assigned to one of two groups. One group will switch from immediate-release tacrolimus to extended-release tacrolimus at 80% of their current total daily dose. Tacrolimus levels will be checked 3 to 4 weeks after the switch to adjust dosing if needed. The other group will continue their current dose of immediate-release tacrolimus unless blood levels fall outside the target range. During the study, participants will undergo assessments of neurocognitive function at 3 and 12 months, including total cognition, fluid reasoning, and crystallized knowledge measured by standardized scores and T scores. Quality of life, tremor, and sleep patterns will also be monitored through questionnaires and wearable devices. The study will last at least 12 months, with close monitoring of kidney function and tacrolimus blood levels to ensure safety and treatment stability.

Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients