Optimizing Prograf® Therapy in Renal Transplant Patients

NCT ID: NCT00297765

Last Updated: 2008-08-26

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

PHASE4

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-03-31

Brief Summary

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A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients.

Detailed Description

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A 3 arm study (2 Active, 1 Active Control) to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients

Conditions

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Renal Transplantation

Keywords

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Renal Transplantation Therapeutics Treatment Outcome Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tacrolimus, Prograf®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient was 18 years of age at the time of transplant.
* Patient is at least 6 months post-transplant.

Exclusion Criteria

* Patient is the recipient of a solid organ transplant other than the kidney.
* Patient is a known carrier of any of the HIV viruses.
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

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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San Diego, California, United States

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San Francisco, 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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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Honolulu, Hawaii, United States

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Peoria, Illinois, United States

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Indianapolis, Indiana, United States

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Shreveport, Louisiana, United States

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Portland, Maine, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Minneapolis, Minnesota, United States

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Omaha, Nebraska, United States

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Livingston, New Jersey, United States

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West Orange, New Jersey, United States

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Buffalo, New York, United States

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Long Island City, New York, United States

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Mineola, New York, 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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New York, New York, United States

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Greenville, North Carolina, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Galveston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Countries

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United States

Other Identifiers

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20-02-002

Identifier Type: -

Identifier Source: org_study_id