Status:
COMPLETED
Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Kidney Transplant; Complications
Toxicity
Eligibility:
All Genders
60+ years
Phase:
PHASE4
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 ...
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. E...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03461445
Start Date
April 1 2018
End Date
July 31 2023
Last Update
April 8 2025
Active Locations (1)
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1
UC Davis
Sacramento, California, United States, 95817