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:
Astellas Pharma Inc
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
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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:
Detailed Description:
-
Drug: tacrolimus
Other Name: Prograf®, FK506
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 |
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 May 23, 2013