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

Purpose

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.

Condition	Intervention	Phase
Liver Transplantation	Drug: tacrolimus	Phase III

MedlinePlus related topics:

Liver Transplantation

ChemIDplus related topics:

Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Incidence of and time to biopsy-proven acute rejections [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of acute rejections [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	476
Study Start Date:	August 2004
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: tacrolimus immunosuppression
2: Experimental	Drug: tacrolimus immunosuppression

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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..

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189826

Show 51 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Principal Investigator:	J. Langrehr	Charite Campus Virchow Klinikum

More Information

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	FG-506E-11-03
First Received:	September 13, 2005
Last Updated:	December 24, 2007
ClinicalTrials.gov Identifier:	NCT00189826
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Directorate general for the protection of Public health: Medicines; Brazil: National Committee of Ethics in Research; Canada: Health Canada; Switzerland: Swissmedic; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; United Kingdom: National Health Service; Ireland: Irish Medicines Board; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Norway: Norwegian Medicines Agency; Poland: Ministry of Health; Sweden: Medical Products Agency

Keywords provided by Astellas Pharma Inc:

Tacrolimus

Liver transplantation

Study placed in the following topic categories:

Tacrolimus

Additional relevant MeSH terms:

Immunologic Factors

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00189826