Clinical trial NCT03461445: Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
Official title: A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant; Complications
Toxicity
Drug Toxicity
Neurotoxicity
Keywords: Elderly
Neurotoxicity
Calcineurin inhibitors
Tacrolimus
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Veloxis Pharmaceuticals
First posted: 2018-03-12
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Change in Neurocognitive Side Effects
timeFrame: 6 weeks after randomization and baseline testing
Secondary outcomes:
measure: Change in Self-reported Side Effects
timeFrame: 6 weeks after randomization and baseline testing
measure: Kidney Graft Survival
timeFrame: 6 months after transplant
measure: Patient Survival
timeFrame: 6 months after transplant
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
Study officials:
affiliation: UC Davis
name: Ling-Xin Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: