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Sponsors and Collaborators: |
Astellas Pharma Inc Astellas Pharma Taiwan, Inc. |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00717678 |
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF in de novo kidney transplant recipients.
Condition | Intervention | Phase |
---|---|---|
Kidney Transplantation Transplantation Immunology Host vs Graft Reaction |
Drug: Prograf-XL Drug: Prograf Drug: MMF |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF and Extended Release (XL) Tacrolimus /MMF in de Novo Kidney Transplant Recipients |
Enrollment: | 73 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Prograf-XL + MMF
|
Drug: Prograf-XL
oral
Drug: MMF
oral
|
2: Active Comparator
Prograf + MMF
|
Drug: Prograf
oral
Drug: MMF
oral
|
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Taiwan | |
Taipei, Taiwan, 100 | |
Taichung, Taiwan, 407 | |
Tainan, Taiwan, 704 | |
Taipei, Taiwan, 112 | |
Taoyuan, Taiwan, 333 |
Study Chair: | Central Contact | Astellas Pharma Inc |
Responsible Party: | Astellas Pharma, Inc ( Director ) |
Study ID Numbers: | PRGXLKTx-0701-TW |
Study First Received: | July 16, 2008 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00717678 History of Changes |
Health Authority: | Taiwan: Department of Health |
Immunosuppressant Combination drug therapy Graft loss Randomized controlled trial Open level method |
Immunologic Factors Mycophenolate mofetil Tacrolimus Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Mycophenolate mofetil |
Tacrolimus Immunosuppressive Agents Pharmacologic Actions |