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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 (CRAF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00510913
First Posted: August 2, 2007
Last Update Posted: August 2, 2007
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.
Information provided by:
Astellas Pharma Inc
  Purpose
A study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure

Condition Intervention Phase
Graft Rejection Kidney Transplantation Drug: tacrolimus Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

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

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

Estimated Enrollment: 450
Study Start Date: February 1999
Study Completion Date: September 2000
Intervention Details:
    Drug: tacrolimus
    Other Name: Prograf®, FK506
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
  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00510913


Locations
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
Investigators
Study Director: John Holman, MD Astellas Pharma Inc
  More Information

ClinicalTrials.gov Identifier: NCT00510913     History of Changes
Other Study ID Numbers: 20-98-002
First Submitted: July 31, 2007
First Posted: August 2, 2007
Last Update Posted: August 2, 2007
Last Verified: July 2007

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

Additional relevant MeSH terms:
Tacrolimus
Cyclosporins
Cyclosporine
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