A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 3/24/2019 |
| Start Date: | April 1, 2018 |
| End Date: | December 13, 2019 |
| Contact: | Ling-Xin Chen, MD |
| Email: | lxchen@ucdavis.edu |
| Phone: | 916.734.5141 |
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.
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.
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.
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.
Inclusion Criteria:
1. Recipient of a kidney transplant
2. Age 65 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
Exclusion Criteria:
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
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