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

July 31, 2007 updated by: Astellas Pharma Inc

Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Georgia
      • Augusta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • New York
      • Albany, New York, United States
      • New York, New York, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Graft Survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient survival, Graft Loss
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: John Holman, MD, Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1999

Study Completion (Actual)

September 1, 2000

Study Registration Dates

First Submitted

July 31, 2007

First Submitted That Met QC Criteria

July 31, 2007

First Posted (Estimate)

August 2, 2007

Study Record Updates

Last Update Posted (Estimate)

August 2, 2007

Last Update Submitted That Met QC Criteria

July 31, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-98-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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