| Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients |
| 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 |
| 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. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment |
| Kidney Transplant |
| Drug: sirolimus |
| Not Provided |
| Flechner SM, Gurkan A, Hartmann A, Legendre CM, Russ GR, Campistol JM, Schena FP, Hahn CM, Li H, Korth-Bradley JM, Tai SS, Schulman SL. A randomized, open-label study of sirolimus versus cyclosporine in primary de novo renal allograft recipients. Transplantation. 2013 May 27;95(10):1233-41. doi: 10.1097/TP.0b013e318291a269. |
| |
| Terminated |
| 500 |
| August 2006 |
| August 2006 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Dialysis patients who will be receiving their first kidney transplant
- Weight over 88 pounds (lbs.)
Exclusion Criteria:
- Very high cholesterol levels
- Obesity
- Organ donor over 65 years of age if living; over 60 years of age if cadaveric.
|
| Sexes Eligible for Study: |
All |
|
| 13 Years and older (Child, Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Australia, Austria, Canada, Chile, Cyprus, France, Germany, Greece, Hungary, Italy, Norway, Portugal, Singapore, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States |
| |
| |
| NCT00137345 |
0468H1-318
B1741188 ( Other Identifier: Pfizer ) |
| Not Provided |
| Not Provided |
| Not Provided |
| Wyeth is now a wholly owned subsidiary of Pfizer |
| Wyeth is now a wholly owned subsidiary of Pfizer |
| Not Provided |
| Study Director: |
Medical Monitor |
Wyeth is now a wholly owned subsidiary of Pfizer |
| Principal Investigator: |
Trial Manager |
For Germany, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Norway, Sweden, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Australia, Taiwan, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Austria, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Italy, Greece, [email protected]
|
| Principal Investigator: |
Trial manager |
For Hungary, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Turkey, [email protected]
|
| Principal Investigator: |
Trial Manager |
For South Africa, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Argentina, Chile, [email protected], [email protected]
|
| Principal Investigator: |
Trial Manager |
For UK, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Switzerland, [email protected]
|
|
| Wyeth is now a wholly owned subsidiary of Pfizer |
| September 2006 |
