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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03461445
Other study ID # 1044220
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 1, 2018
Est. completion date July 31, 2023

Study information

Verified date November 2022
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date July 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Envarsus
Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
IR Tacrolimus
Patients will be randomized to receiving IR Tacrolimus instead of Envarsus

Locations

Country Name City State
United States UC Davis Sacramento California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Davis Veloxis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in neurocognitive side effects 6 weeks after randomization and baseline testing
Secondary Change in self-reported side effects 6 weeks after randomization and baseline testing
Secondary Tacrolimus dose over concentration ratio 6 weeks after randomization and baseline testing
Secondary Kidney graft survival 6 months after transplant
Secondary Patient survival 6 months after transplant
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