Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00189826
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : July 9, 2014
Sponsor:
Information provided by:
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date July 9, 2014
Study Start Date  ICMJE August 2004
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2007)
Incidence of and time to biopsy-proven acute rejections [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2007)
Incidence of acute rejections [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.
Official Title  ICMJE 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
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Liver Transplantation
Intervention  ICMJE Drug: tacrolimus
immunosuppression
Other Name: FK506E, MR4
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: tacrolimus
  • Experimental: 2
    Intervention: Drug: tacrolimus
Publications * Ericzon BG, Varo E, Trunečka P, Fischer L, Colledan M, Gridelli B, Valdivieso A, O'Grady J, Dickinson J, Undre N. Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver transplantation: A randomized phase III substudy. Clin Transplant. 2017 Jun;31(6). doi: 10.1111/ctr.12958. Epub 2017 Apr 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2008)
475
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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..
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   Finland,   France,   Germany,   Ireland,   Italy,   Norway,   Poland,   Spain,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00189826
Other Study ID Numbers  ICMJE FG-506E-11-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Disclosure Office Europe, Astellas Pharma Europe BV
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: J. Langrehr Charite Campus Virchow Klinikum
PRS Account Astellas Pharma Inc
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP