Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients (NCT03461445) | Clinical Trial Compass
CompletedPhase 4
Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
United States64 participantsStarted 2018-04-01
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Change in Neurocognitive Side Effects
Timeframe: 6 weeks after randomization and baseline testing
✕. 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.