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document
Efficacy and safety of de novo or early everolimus with low cyclosporine in deceased-donor kidney transplant recipients at specified risk of delayed graft function : 12-month results of a randomized , multicenter trial . Immediate or early use of proliferation signal inhibitor ( PSI ) /mammalian target of rapamycin ( mTOR ) inhibitor therapy can avoid high exposure to calcineurin inhibitors but concerns exist relating to the risk of delayed graft function ( DGF ) and impaired wound healing with the mTOR sirolimus . CALLISTO was a 12-month , prospective , multicenter , open-label study . Deceased-donor kidney transplant patients at protocol-specified risk of DGF were randomized to start everolimus on day 1 ( immediate everolimus , IE ; n = 65 ) or week 5 ( delayed everolimus , DE ; n = 74 ) . Incidence of the primary endpoint ( biopsy-proven acute rejection , BPAR ; graft loss , death , DGF , wound healing complications related to transplant surgery or loss to follow-up ) was 64.6 % and 66.2 % in the IE and DE groups , respectively , at month 12 ( P = 0.860 ) . The overall incidence of BPAR was 20.1 % . Median estimated glomerular filtration rate was 48 ml/min/1.73 m ( 2 ) and 49 ml/min/1.73 m ( 2 ) in the IE and DE groups , respectively , at month 12 . DGF and wound healing complications were similar between groups . Adverse events led to study drug discontinuation in 17 IE patients ( 26.2 % ) and 28 DE patients ( 37.8 % ) ( NS ) . In conclusion , introduction of everolimus immediately or early posttransplant in DGF-risk patients is associated with good efficacy , renal function and safety profile . There seems no benefit in delaying initiation of everolimus .
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Intervention_Pharmacological
everolimus
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Intervention_Pharmacological
everolimus
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Intervention_Pharmacological
immediate everolimus
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Outcome_Physical
delayed graft function
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Outcome_Other
( DGF
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Outcome_Physical
impaired wound healing