The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)
Non-inferiority of the composite of graft loss and death at 52 weeks
Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks
quality of life at 24, 52 and 104 weeks
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San Diego, California, United States
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San Francisco, California, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Gainesville, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Portland, Maine, United States
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Springfield, Massachusetts, United States
...and 72 more locations