Last updated on April 2018

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


Brief description of study

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.

Detailed Study Description

The investigators will conduct a single-center, prospective, open-label, randomized study to evaluate the difference in neurocognitive side effects between Envarsus and immediate release tacrolimus. Eligible patients will be enrolled within 8 weeks post-transplantation. They will be administered a baseline panel of neurocognitive tests. They will then be randomized to either continue on immediate release tacrolimus or Envarsus. 6 weeks after randomization, the neurocognitive tests will be repeated.

Clinical Study Identifier: NCT03461445

Contact Investigators or Research Sites near you

Start Over

Ling-Xin Chen, MD

UC Davis
Sacramento, CA United States
  Connect »