Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients
NCT00266123
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Adult Trials: 18+ Years
- Age > 18 years.
- End-stage renal disease with subjects scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated mismatched donor, or from a living-related mismatched donor. Unreported HLA values will be considered a match.
- Women of childbearing potential must have a negative serum pregnancy test before administration of assigned treatment and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.
Other inclusions apply.
- Evidence of active systemic or localized major infection.
- Known hypersensitivity to SRL or its derivatives, macrolide antibiotics,
corticosteroids, TAC or MMF.
- Multiple organ transplants (i.e., prior or concurrent transplantation of any organs
other than renal transplant).
Other exclusions apply.
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| Descriptive Information | ||||||||||||||||||||||||||||
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| Brief Title ICMJE | Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients | |||||||||||||||||||||||||||
| Official Title ICMJE | A Randomized Open-Label Study to Compare the Safety and Efficacy of Two Different Sirolimus Regimens With a Tacrolimus + Mycophenolate Mofetil Regimen in De Novo Renal Allograft Recipients | |||||||||||||||||||||||||||
| Brief Summary | To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at month 12 post-transplantation. | |||||||||||||||||||||||||||
| Detailed Description | Not Provided | |||||||||||||||||||||||||||
| Study Type ICMJE | Interventional | |||||||||||||||||||||||||||
| Study Phase ICMJE | Phase 4 | |||||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||||||||||||||||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Sirolimus | |||||||||||||||||||||||||||
| Study Arms ICMJE | Not Provided | |||||||||||||||||||||||||||
| Publications * | Not Provided | |||||||||||||||||||||||||||
* 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 | Completed | |||||||||||||||||||||||||||
| Enrollment ICMJE | 420 | |||||||||||||||||||||||||||
| Original Enrollment ICMJE | Same as current | |||||||||||||||||||||||||||
| Actual Study Completion Date ICMJE | July 2007 | |||||||||||||||||||||||||||
| Primary Completion Date | Not Provided | |||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Other inclusions apply. Exclusion Criteria:
Other exclusions apply. | |||||||||||||||||||||||||||
| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (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 | Not Provided | |||||||||||||||||||||||||||
| Removed Location Countries | ||||||||||||||||||||||||||||
| Administrative Information | ||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00266123 | |||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 0468H1-101497 | |||||||||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||||||||||||||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||||||||
| Responsible Party | Not Provided | |||||||||||||||||||||||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | |||||||||||||||||||||||||||
| Investigators ICMJE |
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| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||||||||
| Verification Date | December 2007 | |||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||||||||||||||||||||