Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients
NCT00137345
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
13 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Dialysis patients who will be receiving their first kidney transplant
- Weight over 88 pounds (lbs.)
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Very high cholesterol levels
- Obesity
- Organ donor over 65 years of age if living; over 60 years of age if cadaveric.
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Advanced Information
| 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 | |||||||||||||||||||||||||||||||||||||