MedTrace Logo

Envarsus XL Immunosuppression Following Liver Transplantation

NCT03828058 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-01-12

No results posted yet for this study

Summary

The standard immunosuppressive regimen for liver transplantation includes twice daily tacrolimus (Prograf). In other transplantation models, there are potential benefits to extended release formulations as lower peak concentrations are thought to have lower rates of nephrotoxicity. Additionally, compliance with once daily medications is felt to be easier than twice daily medications. Our aim is to look at our prospective liver transplant group and see if once daily tacrolimus (Envarsus XR) results in improved renal function as well as improved health care quality of life.

Conditions

  • Recipients of Liver Transplant

Interventions

DRUG

Envarsus XR

Envarsus XR to be administered orally, once a day. Dosage will be adjusted as determined by trough blood levels.

DRUG

Prograf

Prograf 2 mg BID to be administered orally, twice a day. Dosage will be adjusted as determined by trough blood levels.

Sponsors & Collaborators

  • Methodist Healthcare

    lead OTHER

Principal Investigators

  • James Eason, MD · The University of Tennessee Health Science Center, Department of Transplant

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03828058 on ClinicalTrials.gov