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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00064701 |
The purpose of this study is to compare the safety and efficacy of Prograf/MMF, Neoral/MMF and Modified Release (MR) Tacrolimus/MMF in de novo kidney transplant recipients.
Condition | Intervention | Phase |
---|---|---|
Kidney Transplantation |
Drug: Tacrolimus Modified Release (MR) Drug: Tacrolimus Drug: cyclosporine microemulsion Drug: mycophenolate mofetil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF, Modified Release (MR) Tacrolimus/MMF and Neoral (Cyclosporine)/MMF in de Novo Kidney Transplant Recipients |
Enrollment: | 668 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Tacrolimus Modified Release (MR)
Oral
Drug: mycophenolate mofetil
Oral
|
2: Active Comparator
tacrolimus
|
Drug: Tacrolimus
Oral
Drug: mycophenolate mofetil
Oral
|
3: Active Comparator
CsA
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Drug: cyclosporine microemulsion
Oral
Drug: mycophenolate mofetil
Oral
|
This will be a 3 arm randomized, open-label, comparative, multi-center study in de novo kidney transplant recipients. Enrollment will include approximately 660 patients at 60-70 centers in the U.S., Canada and South America.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
Responsible Party: | Astellas Pharma US, Inc ( Sr Manager Clinical Trial Registries ) |
Study ID Numbers: | 02-0-158 |
Study First Received: | July 10, 2003 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00064701 |
Health Authority: | United States: Food and Drug Administration; Brazil: Ministry of Health; Canada: Health Canada |
De Novo Kidney Transplant cyclosporine Prograf® mycophenolate mofetil tacrolimus |
Cyclosporine Clotrimazole Miconazole Tioconazole |
Mycophenolic Acid Mycophenolate mofetil Tacrolimus Cyclosporins |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Antifungal Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents |