An Experimental Comparison Study of Envarsus ® XR and Tacrolimus IR for Elderly Kidney Transplant Patients

This study will test any differences in neurological side effects between two FDA indicated medications to prevent rejection of your kidney.

a study on Kidney Transplant Transplants Toxicity Drug Toxicity Neurotoxicity

Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at Sacramento, California
Dates
study started
completion

Description

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.

Official Title

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

Details

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.

Keywords

Kidney Transplant; Complications, Toxicity, Drug Toxicity, Neurotoxicity, Elderly, Calcineurin inhibitors, Tacrolimus, Neurotoxicity Syndromes, Drug-Related Side Effects and Adverse Reactions, Envarsus, IR Tacrolimus, Immediate Release Tacrolimus

Eligibility

You can join if…

Open to people ages 60 years and up

  1. Recipient of a kidney transplant
  2. Age 60 or greater at the time of transplant
  3. Kidney graft is functional (not dialysis dependent) by 4 weeks post-transplant
  4. Have IR tacrolimus as maintenance therapy
  5. Have BMI < 35 at time of transplant
  6. Achieve therapeutic tacrolimus level within 4 weeks post-transplant

You CAN'T join if...

  1. Recipient of a simultaneous non-kidney transplant (pancreas)
  2. Had an episode of rejection before study enrollment
  3. Had a TIA/CVA after transplantation and before study enrollment
  4. Had a neurologic injury after transplantation and before study enrollment
  5. Blindness
  6. Have an mTOR inhibitor as maintenance therapy
  7. Nonadherence, as determined by a trough level less than 7 ng/mL after achieving therapeutic level with no other rationale for sub-therapeutic levels.
  8. Adults unable to consent
  9. Pregnant women
  10. Prisoners

Location

  • UC Davis
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
University of California, Davis
Links
Learn more or sign up for the study here! Sign up for this study
ID
NCT03461445
Phase
Phase 4 research study
Study Type
Interventional
Participants
About 64 people participating
Last Updated