A Study to Assess the Safety and Efficacy of Prograf and MR4 in Liver Transplant Recipients

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. Identifier: NCT00719745
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : July 22, 2008
Astellas Pharma Korea, Inc.
Information provided by:
Astellas Pharma Inc

Brief Summary:
To evaluate and to compare efficacy and safety of MR4 versus Prograf in patients undergoing primary liver transplantation.

Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: Prograf Drug: MR4 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus) and MR4 (Modified Release Tacrolimus) in de Novo Liver Transplant Recipients
Study Start Date : February 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: Prograf
Other Names:
  • Tacrolimus
  • FK506
Experimental: 2 Drug: MR4
Other Names:
  • Modified Release Tacrolimus
  • FK506MR
  • FK506E

Primary Outcome Measures :
  1. Event rate of patients with biopsy-proven acute rejections [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Incidence of and time to acute rejections and corticosteroid resistant acute rejections [ Time Frame: 12 and 24 weeks ]
  2. Severity of biopsy-proven acute rejections. [ Time Frame: 24 weeks ]
  3. Patient and graft survival [ Time Frame: 12 and 24 weeks ]
  4. Incidence of adverse events [ Time Frame: Throughout trial ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female patients of child bearing potential must have a negative in pregnancy test prior to enrollment and must agree to practice effective birth control during the study
  • Patients who need liver transplantation due to the end-stage liver failure

Exclusion Criteria:

  • Patients receiving multi-organ transplant or having previously received an organ transplant ( including re-transplantation)
  • Patients receiving auxiliary graft or in whom a bio-artificial
  • Patients allergic to macrolide antibiotics or tacrolimus
  • Patients requiring immunosuppressive treatment or systemic chemotherapy prior to transplantation. Patients requiring low level immunosuppressive treatment ( MMF, steroids, azathioprine ) before transplantation to control their original liver disease can be included in the study, provided that this treatment is discontinued at the time of transplantation. Local chemotherapy is allowed
  • Patients with malignancies of a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully Patients can be included under Milan Criteria Patients with malignancy which was identified after completion of surgery e.g. by histopathology will be allowed to remain in the study
  • Patients with systemic infection requiring treatment, except viral hepatitis
  • Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
  • Patients with serum creatinine > 1.5mg/Dl
  • Patients with any form of substance abuse, psychiatric disorder of condition which, in the opinion of the investigator, may complicate communication with the investigator
  • Patients participating or participated in another clinical trial or those taking or having taken an investigational / non-registered drug in the past 28 days
  • Patients who are pregnant or breast-feeding mother
  • Patients or donors known to be HIV positive
  • Patients unlikely to comply with the visits scheduled in the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00719745

Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Study Chair: Central Contact Astellas Pharma Korea, Inc.

Responsible Party: Director, Astellas Pharma Inc. Identifier: NCT00719745     History of Changes
Other Study ID Numbers: MR-05-02-KOR
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: July 22, 2008
Last Verified: July 2008

Keywords provided by Astellas Pharma Inc:
Organ transplantation

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action