Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
Tracking Information | |||||
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First Received Date ICMJE | September 13, 2005 | ||||
Last Updated Date | September 10, 2007 | ||||
Start Date ICMJE | July 2004 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Time-to-event analysis will be used to analyze categorical end points that include graft failure, patient survival, biopsy documented rejection episode and non-compliance. [ Time Frame: 2 years ] | ||||
Original Primary Outcome Measures ICMJE |
Time-to-event analysis will be used to analyze categorical end points that include graft failure, patient survival, biopsy documented rejection episode and non-compliance. | ||||
Change History | Complete list of historical versions of study NCT00177138 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
The continuous outcome variable, weekly or bi-weekly serum creatinine levels, will be analyzed using a two-way repeated-measures analysis of variance. [ Time Frame: 2 years ] | ||||
Original Secondary Outcome Measures ICMJE |
The continuous outcome variable, weeily or bi-weekly serum creatinine levels, will be analyzed using a two-way repeated-measures analysis of variance. | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation | ||||
Official Title ICMJE | Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation | ||||
Brief Summary | 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. |
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Detailed Description | Secondary objectives of the study are:
Comparison parameters are:
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Enrollment ICMJE | 9 | ||||
Completion Date | November 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 60 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00177138 | ||||
Other Study ID Numbers ICMJE | 0308M51264, Berlex Study No. 107.G0001 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | |||||
Study Sponsor ICMJE | University of Minnesota - Clinical and Translational Science Institute | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | University of Minnesota - Clinical and Translational Science Institute | ||||
Verification Date | September 2007 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |