![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Astellas Pharma Inc Astellas Pharma Canada, Inc. |
---|---|
Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00637143 |
The purpose of this study is to compare renal transplant recipients on cyclosporine maintenance therapy vs. those converted to tacrolimus-based immunosuppression with respect to renal outcomes.
Condition | Intervention | Phase |
---|---|---|
Renal Transplantation Chronic Renal Allograft Failure |
Drug: Tacrolimus Drug: Cyclosporine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure |
Enrollment: | 107 |
Study Start Date: | April 1999 |
Study Completion Date: | February 2006 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Tacrolimus
Oral
|
2: Active Comparator |
Drug: Cyclosporine
Oral
|
The objective of this study is to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine to tacrolimus-based immunosuppression to patients who remain on cyclosporine.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient has one of the following risk factors for chronic renal allograft failure at the baseline biopsy:
Exclusion Criteria:
Canada, Alberta | |
Edmonton, Alberta, Canada, T6G 2B7 | |
Calgary, Alberta, Canada, T2N 2T9 | |
Canada, British Columbia | |
Vancouver, British Columbia, Canada, V5Z 1M9 | |
Canada, Manitoba | |
Winnipeg, Manitoba, Canada, R3A 1R9 | |
Canada, Newfoundland and Labrador | |
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |
Canada, Nova Scotia | |
Halifax, Nova Scotia, Canada, B3H 1V8 | |
Canada, Ontario | |
Hamilton, Ontario, Canada, L8N 4A6 | |
Toronto, Ontario, Canada, M5G 2N2 | |
London, Ontario, Canada, N6A 5A5 | |
Toronto, Ontario, Canada, M5C 2T2 | |
Canada, Quebec | |
Montreal, Quebec, Canada, H1T 2M4 | |
Montreal, Quebec, Canada, H3A 1A1 | |
Canada, Saskatchewan | |
Saskatoon, Saskatchewan, Canada, S7M 0Z9 |
Study Chair: | Central Contact | Astellas Pharma Canada, Inc. |
Responsible Party: | Astellas Pharma US, Inc. ( Sr Manager, Clinical Trial Registry ) |
Study ID Numbers: | FKC-003 |
Study First Received: | March 10, 2008 |
Last Updated: | January 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00637143 |
Health Authority: | Canada: Health Canada |
Renal transplant Tacrolimus Cyclosporine |
Intervention Chronic Renal Allograft Failure Interstitial Fibrosis Tubular Atrophy |
Cyclosporine Clotrimazole Fibrosis Miconazole Tioconazole |
Neoplasm Metastasis Atrophy Tacrolimus Cyclosporins |
Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antifungal Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antirheumatic Agents Dermatologic Agents Immunosuppressive Agents Pharmacologic Actions |