Diabetes Mellitus Clinical Trial
Official title:
Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
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.
Secondary objectives of the study are:
1. Compare the side effects of the immunosuppressive medications between both groups. This
will include anaphylactic reactions, GI side-effects, bone marrow suppression, renal
dysfunction, hypertension, hyperglycemic effects, and effects on lipid profile.
2. Compare the incidence of infections between both groups.
Comparison parameters are:
1. Pancreas and kidney graft failure
2. Patient death
3. Clinical and biopsy documented rejection episodes
4. Patient dropout (non-compliance with the study protocol)
5. Kidney function as assessed by creatinine clearance or biopsy
6. Need to change immunosuppression regimen
7. Quality-adjusted Life Years
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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