CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 64 enrolled
Drug / intervention
Envarsus +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03461445
NCT03461445Phase 4Completed
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A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients

University of California, Davis·interventional·Posted Mar 12, 2018·Updated Apr 8, 2025

In Brief

A Phase 4 clinical trial evaluating Envarsus and IR Tacrolimus for Kidney Transplant; Complications and 3 related conditions. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplant; Complications, Toxicity, Drug Toxicity, Neurotoxicity
CountriesUnited States
CollaboratorsVeloxis Pharmaceuticals

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 12, 2018
Enrollment StartApr 1, 2018
Primary CompletionJul 31, 2023
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 8.3 years ago

Interventions

Envarsusdrug

Patients will be randomized to receiving Envarsus instead of IR Tacrolimus

IR Tacrolimusdrug

Patients will be randomized to receiving IR Tacrolimus instead of Envarsus