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Sponsors and Collaborators: |
University of Minnesota Bayer Gruessner, Rainer, MD |
Information provided by: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00177138 |
This is a single center, prospective, open-label, randomized trial at the University of Minnesota Medical Center,Fairview.
Primary objectives are to determine if rejection episodes and loss rates, graft survival, level of renal graft function, and patient survival rates with a Campath/MMF-based (Group 1) immunosuppressive protocol are lower than, or equal to, our protocol using thymoglobulin, tacrolimus, and MMF (Group 2).
This study will investigate the first protocol that is both steroid-free and calcineurin inhibitor-free in pancreas after kidney transplant recipients.
Condition | Intervention | Phase |
Diabetes Mellitus |
Drug: Tacrolimus Drug: Alemtuzumab |
Phase IV |
MedlinePlus related topics: | Diabetes Kidney Transplantation |
Drug Information available for: | Tacrolimus Alemtuzumab Campath Tacrolimus anhydrous Pancrelipase Ultrase |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation |
Enrollment: | 9 |
Study Start Date: | July 2004 |
Study Completion Date: | November 2006 |
Arms | Assigned Interventions |
Group 2: Active Comparator
Tacrolimus/MMF/TMG
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Drug: Tacrolimus
Starting POD #1 0.06 mg/kg/day in 2 divided doses;
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Group 1: Experimental
Campath/MMF/TMG
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Drug: Alemtuzumab
30 mg IV intra-op and POD #12; then 30 mg IV >monthly for 1 year (only if ALC>200 mm, up to a total of 10 doses in year)
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Secondary objectives of the study are:
Comparison parameters are:
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Enteric or bladder drained pancreas transplant.
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Exclusion Criteria:
United States, Minnesota | |||||
University of Minnesota-Fairview | |||||
Minneapolis, Minnesota, United States, 55414 |
University of Minnesota |
Bayer |
Gruessner, Rainer, MD |
Principal Investigator: | Rainer W Gruessner, M.D. | University of Minnesota |
Study ID Numbers: | 0308M51264, Berlex Study No. 107.G0001 |
First Received: | September 13, 2005 |
Last Updated: | September 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00177138 |
Health Authority: | United States: Institutional Review Board |
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