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A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.

NCT00189826 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2014-07-09

No results posted yet for this study

Summary

To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

Conditions

  • Liver Transplantation

Interventions

DRUG

tacrolimus

immunosuppression

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • J. Langrehr · Charite Campus Virchow Klinikum

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Ireland
  • Italy
  • Norway
  • Poland
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT00189826 on ClinicalTrials.gov