New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Proportion of patients who no longer require a hypoglycemic agent, or who move from insulin to an oral agent, or who no longer meet the American Diabetes Association criteria, or a relative improvement in mean glycosylated hemoglobin at 12 and 26 weeks
Safety assessed by death, graft loss, biopsy supported clinically manifested acute rejection, change in kidney function, change in liver function, serious adverse events and adverse events at 12 and 26 weeks
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