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

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

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

Study Overview

• Status: Completed
• Conditions: Liver Transplantation
• Intervention / Treatment: Drug: Prograf; Drug: MR4

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2	Drug: MR4; oral; Other Names: FK506E; Modified Release Tacrolimus; FK506MR
Active Comparator: 1	Drug: Prograf; oral; Other Names: FK506; Tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Event rate of patients with biopsy-proven acute rejections	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of and time to acute rejections and corticosteroid resistant acute rejections	12 and 24 weeks
Severity of biopsy-proven acute rejections.	24 weeks
Patient and graft survival	12 and 24 weeks
Incidence of adverse events	Throughout trial

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: Astellas Pharma Korea, Inc.
• Investigators: Study Chair: Central Contact, Astellas Pharma Korea, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: July 18, 2008
• First Submitted That Met QC Criteria: July 18, 2008
• First Posted (Estimate): July 22, 2008

Study Record Updates

• Last Update Posted (Estimate): July 22, 2008
• Last Update Submitted That Met QC Criteria: July 18, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Tacrolimus; MR4; Prograf; Organ transplantation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: MR-05-02-KOR