Trials / Completed
CompletedNCT03461445
Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- University of California, Davis · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Envarsus | Patients will be randomized to receiving Envarsus instead of IR Tacrolimus |
| DRUG | IR Tacrolimus | Patients will be randomized to receiving IR Tacrolimus instead of Envarsus |
Timeline
- Start date
- 2018-04-01
- Primary completion
- 2023-07-31
- Completion
- 2023-07-31
- First posted
- 2018-03-12
- Last updated
- 2025-04-08
- Results posted
- 2025-04-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03461445. Inclusion in this directory is not an endorsement.