Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
Completed · Phase 4
Conditions studied: Kidney Transplant; Complications, Toxicity, Drug Toxicity, Neurotoxicity
In brief
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.
Key facts
- Study ID
- NCT03461445
- Run by
- University of California, Davis
- People needed
- 64
- Starts
- 2018-04-01
- Expected to finish
- 2023-07-31
- Last updated by the study team
- 2025-04-08
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Recipient of a kidney transplant
- Age 60 or greater at the time of transplant
- Kidney graft is functional (not dialysis dependent) by 4 weeks post-transplant
- Have IR tacrolimus as maintenance therapy
- Have BMI < 35 at time of transplant
- Achieve therapeutic tacrolimus level within 4 weeks post-transplant
You may not qualify if…
- Recipient of a simultaneous non-kidney transplant (pancreas)
- Had an episode of rejection before study enrollment
- Had a TIA/CVA after transplantation and before study enrollment
- Had a neurologic injury after transplantation and before study enrollment
- Blindness
- Have an mTOR inhibitor as maintenance therapy
- Nonadherence, as determined by a trough level less than 7 ng/mL after achieving therapeutic level with no other rationale for sub-therapeutic levels.
- Adults unable to consent
- Pregnant women
- Prisoners
Where it is running
- UC Davis — Sacramento, California, United States
Full record on ClinicalTrials.gov
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