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

NCT00719745 | Completed Phase 3

• 1 other identifier: MR-05-02-KOR
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Transplantation

Keywords

Organ transplantation; Tacrolimus; Prograf; MR4

Outcome Measures

Primary Outcomes (1)

• Event rate of patients with biopsy-proven acute rejections

  24 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Prograf

2

EXPERIMENTAL

Drug: MR4

Interventions

Prograf DRUG

oral

Also known as: Tacrolimus, FK506

1

MR4 DRUG

oral

Also known as: Modified Release Tacrolimus, FK506MR, FK506E

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Korea, Inc.: collaborator

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Central Contact

  Astellas Pharma Korea, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 22, 2008
• Study Start: February 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 22, 2008

Record last verified: 2008-07

Locations

KR (1)