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

Sponsor

University of California, Davis (Other)

Overall Status

Recruiting

CT.gov ID

NCT03461445

Collaborator

Veloxis Pharmaceuticals (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant; Complications Toxicity Drug Toxicity Neurotoxicity	Drug: Envarsus Drug: IR Tacrolimus	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Immediate Release Tacrolimus Patients will receive immediate release tacrolimus	Drug: IR Tacrolimus Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
Experimental: Envarsus Patients will be converted to Envarsus formulation of tacrolimus	Drug: Envarsus Patients will be randomized to receiving Envarsus instead of IR Tacrolimus

Arm

Intervention/Treatment

Active Comparator: Immediate Release Tacrolimus

Patients will receive immediate release tacrolimus

Drug: IR Tacrolimus

Patients will be randomized to receiving IR Tacrolimus instead of Envarsus

Experimental: Envarsus

Patients will be converted to Envarsus formulation of tacrolimus

Drug: Envarsus

Patients will be randomized to receiving Envarsus instead of IR Tacrolimus

Outcome Measures

Primary Outcome Measures

Change in neurocognitive side effects [6 weeks after randomization and baseline testing]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Recipient of a kidney transplant
Age 65 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