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Sponsored by: |
University of Wisconsin, Madison |
Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00167661 |
The purpose of this study is to determine whether Campath-1H induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.
Condition | Intervention | Phase |
Renal Transplantation |
Drug: Campath-1H |
Phase I Phase II |
MedlinePlus related topics: | Kidney Transplantation |
ChemIDplus related topics: | Alemtuzumab Campath |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation |
Estimated Enrollment: | 35 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
campath
|
Drug: Campath-1H
two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
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Ages Eligible for Study: | 18 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sharon M. Bartosh, MD | 608-265-6020 | smbartosh@wisc.edu |
United States, Wisconsin | |||||
University of Wisconsin Hospital and Clinics | Recruiting | ||||
Madison, Wisconsin, United States, 53792 | |||||
Contact: Sharon M Bartosh, MD 608-265-6020 smbartosh@wisc.edu |
University of Wisconsin, Madison |
Study Chair: | Sharon M Bartosh, MD | University of Wisconsin, Madison |
Principal Investigator: | Sharon M Bartosh, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin ( Sharon M Bartosh, MD ) |
Study ID Numbers: | 2003-0493 |
First Received: | September 11, 2005 |
Last Updated: | December 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00167661 |
Health Authority: | United States: Food and Drug Administration |
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