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About
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.
Full description
Secondary objectives of the study are:
Comparison parameters are:
Enrollment
Sex
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Volunteers
Inclusion criteria
Previous kidney transplant from a living or deceased donor and a deceased- donor pancreas transplant.
Recipient age 18-60 years
Donor age 10-59 years
Females of childbearing potential should have a negative pregnancy test, and agree to practice birth control for the duration of the study.
Enteric or bladder drained pancreas transplant.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
9 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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