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

NCT ID: NCT00719745

Last Updated: 2008-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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Conditions

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Liver Transplantation

Keywords

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Organ transplantation Tacrolimus Prograf MR4

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Prograf

Intervention Type DRUG

oral

2

Group Type EXPERIMENTAL

MR4

Intervention Type DRUG

oral

Interventions

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Prograf

oral

Intervention Type DRUG

MR4

oral

Intervention Type DRUG

Other Intervention Names

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Tacrolimus FK506 Modified Release Tacrolimus FK506MR FK506E

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma Inc.

Principal Investigators

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Central Contact

Role: STUDY_CHAIR

Astellas Pharma Korea, Inc.

Locations

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Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MR-05-02-KOR

Identifier Type: -

Identifier Source: org_study_id