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

Liver Transplantation Clinical Trial

Official title:

A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With Steroids in Patients Undergoing Primary Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189826
• Other study ID #: FG-506E-11-03
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: July 7, 2014
• Start date: August 2004
• Est. completion date: December 2006

Study information

• Verified date: July 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHPBrazil: National Committee of Ethics in ResearchCanada: Health CanadaSwitzerland: SwissmedicCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: National Health ServiceIreland: Irish Medicines BoardItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthNorway: Norwegian Medicines AgencyPoland: Ministry of HealthSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Description:

A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a dual modified release FK506E (MR4) / steroid regimen with a standard tacrolimus FK506 / steroid regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients receiving a primary, split liver or a whole liver graft from a cadaveric donor with compatible ABO blood type.

Exclusion Criteria:

• Patients receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation).

• Patients with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus.

• Patients with serum creatinine > 200 µmol/l..

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• tacrolimus
immunosuppression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Australia,  Belgium,  Brazil,  Canada,  Czech Republic,  Finland,  France,  Germany,  Ireland,  Italy,  Norway,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of and time to biopsy-proven acute rejections		12 months	No
Secondary	Incidence of acute rejections		12 months	No

External Links

•   Link to Results on JAPIC - enter 140497 in the JapicCTI-RNo. field