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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00189826 |
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 |
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 |
Enrollment: | 475 |
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
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2: Experimental |
Drug: tacrolimus
immunosuppression
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | J. Langrehr | Charite Campus Virchow Klinikum |
Responsible Party: | Astellas Pharma Europe BV ( Disclosure Office Europe ) |
Study ID Numbers: | FG-506E-11-03 |
Study First Received: | September 13, 2005 |
Last Updated: | December 4, 2008 |
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 |
Tacrolimus Liver transplantation |
Tacrolimus |
Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |