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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Transplant; Complications, Toxicity, Drug Toxicity, Neurotoxicity

Intervention / Treatment
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* Drug: Envarsus
* Drug: IR Tacrolimus


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate Release Tacrolimus<br>Patients will receive immediate release tacrolimus | Drug: IR Tacrolimus<br>* Patients will be randomized to receiving IR Tacrolimus instead of Envarsus<br>|
| Experimental: Envarsus<br>Patients will be converted to Envarsus formulation of tacrolimus | Drug: Envarsus<br>* Patients will be randomized to receiving Envarsus instead of IR Tacrolimus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neurocognitive side effects |  | 6 weeks after randomization and baseline testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported side effects |  | 6 weeks after randomization and baseline testing | 
| Tacrolimus dose over concentration ratio |  | 6 weeks after randomization and baseline testing | 
| Kidney graft survival |  | 6 months after transplant | 
| Patient survival |  | 6 months after transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Neurotoxicity, Calcineurin inhibitors, Tacrolimus