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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00510913
Recruitment Status : Completed
First Posted : August 2, 2007
Last Update Posted : August 2, 2007
Information provided by:
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Graft Rejection Kidney Transplantation Drug: tacrolimus Phase 4

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  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
Study Start Date : February 1999
Actual Study Completion Date : September 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: tacrolimus
    Other Name: Prograf®, FK506

Primary Outcome Measures :
  1. Graft Survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Patient survival, Graft Loss [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00510913

United States, California
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Georgia
Augusta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, New York
Albany, New York, United States
New York, New York, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: John Holman, MD Astellas Pharma Inc Identifier: NCT00510913     History of Changes
Other Study ID Numbers: 20-98-002
First Posted: August 2, 2007    Key Record Dates
Last Update Posted: August 2, 2007
Last Verified: July 2007

Keywords provided by Astellas Pharma Inc:
Treatment efficacy
Transplantation rejection
Kidney transplantation

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents