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Everolimus Post Orthotopic Liver Transplant

NCT01998789 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-08-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of an everolimus conversion (EVR) protocol as compared to the standard tacrolimus (TAC) based protocol in liver transplant recipients, as determined by renal function, rejection rates, and progression to fibrosis (in HCV positive subjects). Additionally, safety profile and tolerability of these regimens will be assessed.

Conditions

  • Orthotopic Liver Transplant

Interventions

DRUG

Everolimus

Everolimus will be initiated within 24 hours of baseline at a dose of 1 mg po BID (2 mg/day).

DRUG

Standard Tacrolimus

Subjects will be maintained on standard maintenance immunosuppression per local protocol, consisting of a tacrolimus plus enteric coated mycophenolic acid. Oral corticosteroids may not be eliminated sooner than 180 days post transplantation. Tacrolimus doses will be adjusted based on local lab results of tacrolimus trough levels.

Sponsors & Collaborators

  • Tomoaki Kato

    lead OTHER

Principal Investigators

  • Tomoaki Kato, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2018-06-30
Completion
2019-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01998789 on ClinicalTrials.gov