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Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients

NCT03461445 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-04-08

Study results available
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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.

Conditions

  • Kidney Transplant; Complications
  • Toxicity
  • Drug Toxicity
  • Neurotoxicity

Interventions

DRUG

Envarsus

Patients will be randomized to receiving Envarsus instead of IR Tacrolimus

DRUG

IR Tacrolimus

Patients will be randomized to receiving IR Tacrolimus instead of Envarsus

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    collaborator INDUSTRY

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Ling-Xin Chen, MD · UC Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2023-07-31
Completion
2023-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461445 on ClinicalTrials.gov