| August 25, 2005 |
| September 6, 2006 |
| June 2005 |
| |
- To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)
- Non-inferiority of the composite of graft loss and death at 52 weeks
|
| To demonstrate superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate(GFR). Non-inferiority of the composite of graft loss and death at 52 weeks. |
| Complete list of historical versions of study NCT00137345 on ClinicalTrials.gov Archive Site |
- Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks
- quality of life at 24, 52 and 104 weeks
|
| Incidence and severity of rejection at 12, 24, 52, 104,156, 208 weeks; GFR at 24, 104, 156, 208 weeks;progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weekS;quality of life at 24, 52 and 104 weeks. |
| |
| 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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Kidney Transplant |
| Drug: sirolimus |
| |
| |
| |
| Terminated |
| 500 |
|
|
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.
|
| Both |
| 13 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Argentina, Australia, Austria, Canada, Chile, Cyprus, France, Germany, Greece, Hungary, Italy, Norway, Portugal, Singapore, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom |
| |
| NCT00137345 |
|
| 0468H1-318 |
| 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 |
|
|
| Wyeth |
| September 2006 |
