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document
The efficacy and safety of cyclosporine reduction in de novo renal allograft patients receiving sirolimus and corticosteroids : results from an open-label comparative study . This study evaluated the safety and efficacy of a sirolimus , corticosteroid , and cyclosporine reduction regimen in an open-label , 12-month trial of 420 de novo renal allograft recipients at 49 European transplant centers . One month post-transplantation , 357 patients were randomized to receive standard-dose cyclosporine ( sCsA , n = 179 ) or reduced-dose cyclosporine ( rCsA , n = 178 ) . All patients also received sirolimus and corticosteroids . The primary end points were the rate of biopsy-confirmed acute rejection ( BCAR ) and renal function , as measured by serum creatinine . Baseline demographic and donor characteristics were similar between groups . BCAR rates at 12 months were not significantly different : 11.2 % for rCsA patients and 16.2 % for sCsA patients . Mean serum creatinine ( ±SEM ) was significantly lower ( 1.75 ± 0.10 vs. 1.97 ± 0.07 mg/dl , P < 0.001 ) , and creatinine clearance ( ±SEM ; Nankivell method ) was significantly higher ( 57.8 ± 1.78 vs. 49.5 ± 2.46 ml/min , P < 0.001 ) in patients receiving rCsA versus sCsA at 1 year , respectively . Patient and graft survival exceeded 98 % in both groups . No significant differences in infection or malignancy were noted between groups . The rCsA with sirolimus and corticosteroid regimen resulted in excellent 12-month patient and graft survival , a low incidence of BCAR , and improved renal function in renal allograft recipients . Sirolimus administered with rCsA and corticosteroids provided adequate immunosuppression while reducing the potential for the nephrotoxic effects of cyclosporine . These findings may help to improve long-term renal allograft outcomes .
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Intervention_Pharmacological
cyclosporine
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Intervention_Pharmacological
sirolimus , corticosteroid , and cyclosporine
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Intervention_Pharmacological
standard-dose cyclosporine
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Intervention_Pharmacological
reduced-dose cyclosporine
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Intervention_Pharmacological
sirolimus
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Intervention_Pharmacological
corticosteroids
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Outcome_Other
efficacy and safety
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Outcome_Other
safety and efficacy
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Outcome_Physical
rate of biopsy-confirmed acute rejection ( BCAR )
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Outcome_Physical
renal function
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Outcome_Physical
serum creatinine
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Outcome_Physical
BCAR
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Outcome_Physical
Mean serum creatinine
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Participant_Condition
receiving sirolimus and corticosteroids
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Participant_Sample-size
420
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Participant_Condition
de novo renal allograft
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Participant_Sample-size
357