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A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients

NCT ID: NCT00720265

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

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-03-31

Brief Summary

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To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients

Detailed Description

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Conditions

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Kidney Transplantation

Keywords

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Organ Transplantation Tacrolimus Prograf FK506MR

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

* Patient must receive first oral dose of randomized study drug 2days(min 1day) prior to transplant procedure
* Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment

Exclusion Criteria

* Patient has previously received an organ transplant other than a kidney
* Patient has received a Kidney transplant from non-heart beating donor or a cadaveric donor
* Patients has received an ABO incompatible donor kidney
* Recipient or donor is known to be seropositive for human immunodeficiency virus(HIV)
* Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
* Patient has significant liver, disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
* Patient has an uncontrolled concomitant infection(including Hepatitis B, Hepatitis C)or any other unstable medical condition that could interfere with the study objectives
* Patient is currently taking or has been taking an immunosuppressive agents in the 30 days prior to transplant(except from two days prior to transplant)
* Patient has a known hypersensitivity to tacrolimus
* Patient is pregnant or lactating
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 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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Daegu, , South Korea

Site Status

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MR-05-01-KOR

Identifier Type: -

Identifier Source: org_study_id