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| Sponsored by: |
Wyeth |
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00137345 |
Purpose
The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.
| Condition | Intervention | Phase |
|
Kidney Transplant |
Drug: sirolimus |
Phase III |
| MedlinePlus related topics: | Kidney Transplantation |
| ChemIDplus related topics: | Cyclosporine Cyclosporin Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Corticosteroids Sirolimus Basiliximab |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients |
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2005 |
Eligibility
| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations |
Show 82 Study Locations |
| Wyeth |
| Study Director: | Medical Monitor | Wyeth |
| Principal Investigator: | Trial Manager | For Germany, MedInfoDEU@wyeth.com |
| Principal Investigator: | Trial Manager | For Norway, Sweden, MedInfoNord@wyeth.com |
| Principal Investigator: | Trial Manager | For Australia, Taiwan, medinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Austria, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Italy, Greece, decresg@wyeth.com |
| Principal Investigator: | Trial manager | For Hungary, WPBUMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Turkey, Erisc@wyeth.com |
| Principal Investigator: | Trial Manager | For South Africa, ZAFinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Argentina, Chile, scheima@wyeth.com, rendop@wyeth.com |
| Principal Investigator: | Trial Manager | For UK, ukmedonfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Switzerland, med@wyeth.com |
More Information
| Study ID Numbers: | 0468H1-318 |
| First Received: | August 25, 2005 |
| Last Updated: | September 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00137345 |
| Health Authority: | European Union: European Medicines Agency; United States: Food and Drug Administration |
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