A Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients

NCT ID: NCT00282230

Last Updated: 2012-06-07

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-10-31

Brief Summary

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A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients

Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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FK778

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living donor kidney.
* Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure.

Exclusion Criteria

* Patient has received or is receiving an organ transplant other than kidney
* Patient has received a kidney transplant from a cadaveric donor \>= 60 years of age.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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John Holman, MD

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Birmingham, Alabama, United States

Site Status

Los Angeles, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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New Orleans, Louisiana, United States

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Detroit, Michigan, United States

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New Brunswick, New Jersey, United States

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New York, New York, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Harrisburg, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Salt Lake City, Utah, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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03-0-165

Identifier Type: -

Identifier Source: org_study_id

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