A Study to Compare the Conversion to Prograf® (Tacrolimus) to the Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure

NCT ID: NCT00510913

Last Updated: 2007-08-02

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

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-28

Study Completion Date

2000-09-30

Brief Summary

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A study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure

Detailed Description

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A two arm study (1 Active, 1 Active control) to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine-based to tacrolimus-based immunosuppression to patients who remain on cyclosporine-based therapy

Conditions

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Graft Rejection Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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tacrolimus

Intervention Type DRUG

Other Intervention Names

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Prograf®, FK506

Eligibility Criteria

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Inclusion Criteria

* Patient has been on cyclosporine-based immunosuppression regimen since the transplant
* Patient has at least one pre-defined risk factor for chronic allograft failure

Exclusion Criteria

* Patient is dialysis dependent
* Patient is recipient of a solid organ transplant other than the kidney
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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John Holman, MD

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Los Angeles, California, United States

Site Status

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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New Haven, Connecticut, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Albany, New York, United States

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New York, New York, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Nashville, 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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Countries

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United States

Other Identifiers

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20-98-002

Identifier Type: -

Identifier Source: org_study_id