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Sponsored by: |
University of Wisconsin, Madison |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00585130 |
To investigate the safety and efficacy of a treatment regimen consisting of induction therapy with Campath-1H and tacrolimus, followed by sirolimus monotherapy in renal transplant patients, and to evaluate this regimen's potential to enable the eventual discontinuation of long-term immunosuppressive therapy.
Condition | Intervention |
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Kidney Transplantation |
Drug: Campath, sirolimus |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Use of Campath-1H, Tacrolimus, and Sirolimus Followed by Sirolimus Withdrawal in Renal Transplant Patients |
Estimated Enrollment: | 10 |
Study Start Date: | August 2003 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Campath induction, tacrolimus for 2 months, then sirolimus monotherapy (followed by sirolimus withdrawal at 1 year if eligible)
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Drug: Campath, sirolimus
Campath-1H 30mg POD 0 and 1, sirolimus monotherapy, weaned at 1 year if eligible
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Stuart Knechtle, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin ( Stuart Knechtle, MD ) |
Study ID Numbers: | 2003-0435, ITN013ST |
Study First Received: | December 26, 2007 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00585130 |
Health Authority: | United States: Food and Drug Administration |
Sirolimus Clotrimazole Miconazole |
Alemtuzumab Tioconazole Tacrolimus |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |