Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans
NCT00189202
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- African American recipient race
- Solitary cadaveric or living donor renal transplantation
- Age ≥18years at the time of transplantation
- Negative pregnancy serum test in females with childbearing potential
- Age < 18 years at the time of transplantation
- Multi-organ transplant recipient
- Currently taking steroids
- White Blood Cell Count < 3,000
- Platelet count < 100,000
- Triglycerides >400mg/dL
- Cholesterol > 350 mg/dL
- Unwillingness to comply with study procedures
- Allergic reaction to sirolimus Allergy to polyclonal antilymphocyte drugs
(Thymoglobulin)
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Descriptive Information | ||||
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Brief Title ICMJE | Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans | |||
Official Title ICMJE | Efficacy of Sirolimus-Based, Steroid Avoidance Maintenance Immunosuppression in Black de Novo Kidney Transplant Recipients | |||
Brief Summary | African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. This increase in immunosuppression puts this group at risk for drug-related toxicities and complications such as post-transplant diabetes. This study will evaluate:
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Detailed Description | This is an open labeled prospective trial with race matched historical controls. The treatment group (experimental arm) will be African American de novo solitary renal transplant recipients. The control arm will consist of race matched solitary renal transplant recipients who received a Cyclosporine (CsA) -based immunosuppressive regimen. The subjects will be matched for organ source (living donor vs. cadaveric). The experimental treatment arm will have an immunosuppression regimen consisting of Sirolimus, Reduced dose cyclosporine, Thymoglobulin, and only 3 doses of steroids. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: Sirolimus
Thymoglobulin induction, sirolimus and no maintenance corticosteroid Other Name: Rapamune | |||
Study Arms ICMJE | Experimental: Sirolimus, steroid avoidance arm
Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Intervention: Drug: Sirolimus | |||
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 | |||
Actual Enrollment ICMJE | 49 | |||
Original Enrollment ICMJE | 35 | |||
Actual Study Completion Date ICMJE | July 1, 2008 | |||
Actual Primary Completion Date | July 1, 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00189202 | |||
Other Study ID Numbers ICMJE | Steroid Avoidance in A.A. | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Akinlolu Ojo, University of Michigan | |||
Study Sponsor ICMJE | University of Michigan | |||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | University of Michigan | |||
Verification Date | February 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |