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:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00510913
First received: July 31, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00510913     History of Changes
Other Study ID Numbers: 20-98-002
Study First Received: July 31, 2007
Last Updated: July 31, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 15, 2014