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.
- Dialysis patients who will be receiving their first kidney transplant
- Weight over 88 pounds (lbs.)
- Very high cholesterol levels
- Obesity
- Organ donor over 65 years of age if living; over 60 years of age if cadaveric.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | |||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients | ||||||||||||||||||||||||||||||||||||
| Official Title ICMJE | 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 | ||||||||||||||||||||||||||||||||||||
| Brief Summary | 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. | ||||||||||||||||||||||||||||||||||||
| Detailed Description | Not Provided | ||||||||||||||||||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||||||||
| Study Phase ICMJE | Phase 3 | ||||||||||||||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||||||||||||||||||||||||||||||
| Condition ICMJE | Kidney Transplant | ||||||||||||||||||||||||||||||||||||
| Intervention ICMJE | Drug: sirolimus | ||||||||||||||||||||||||||||||||||||
| Study Arms ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||
| Publications * | 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. | ||||||||||||||||||||||||||||||||||||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||||||||||||||||||||||||||
| Recruitment Information | |||||||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Terminated | ||||||||||||||||||||||||||||||||||||
| Enrollment ICMJE | 500 | ||||||||||||||||||||||||||||||||||||
| Original Enrollment ICMJE | Same as current | ||||||||||||||||||||||||||||||||||||
| Actual Study Completion Date ICMJE | August 2006 | ||||||||||||||||||||||||||||||||||||
| Actual Primary Completion Date | August 2006 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||||||||||||||||||||||||||||||||
| Sex/Gender ICMJE |
| ||||||||||||||||||||||||||||||||||||
| Ages ICMJE | 13 Years and older (Child, Adult, Older Adult) | ||||||||||||||||||||||||||||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||||||
| Listed Location Countries ICMJE | Argentina, Australia, Austria, Canada, Chile, Cyprus, France, Germany, Greece, Hungary, Italy, Norway, Portugal, Singapore, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States | ||||||||||||||||||||||||||||||||||||
| Removed Location Countries | |||||||||||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00137345 | ||||||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 0468H1-318 B1741188 ( Other Identifier: Pfizer ) | ||||||||||||||||||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||||||||||||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||||||||||||||||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||
| Investigators ICMJE |
| ||||||||||||||||||||||||||||||||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||||||||||||||
| Verification Date | September 2006 | ||||||||||||||||||||||||||||||||||||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||||||||||||||||||||||||||||||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
