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document
A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients ( BENEFIT study ) . Belatacept , a costimulation blocker , may preserve renal function and improve long-term outcomes versus calcineurin inhibitors in kidney transplantation . This Phase III study ( Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial ) assessed a more intensive ( MI ) or less intensive ( LI ) regimen of belatacept versus cyclosporine in adults receiving a kidney transplant from living or standard criteria deceased donors . The co-primary endpoints at 12 months were patient/graft survival , a composite renal impairment endpoint ( percent with a measured glomerular filtration rate ( mGFR ) < 60 mL/min/1.73 m ( 2 ) at Month 12 or a decrease in mGFR > or =10 mL/min/1.73 m ( 2 ) Month 3-Month 12 ) and the incidence of acute rejection . At Month 12 , both belatacept regimens had similar patient/graft survival versus cyclosporine ( MI : 95 % , LI : 97 % and cyclosporine : 93 % ) , and were associated with superior renal function as measured by the composite renal impairment endpoint ( MI : 55 % ; LI : 54 % and cyclosporine : 78 % ; p < or = 0.001 MI or LI versus cyclosporine ) and by the mGFR ( 65 , 63 and 50 mL/min for MI , LI and cyclosporine ; p < or = 0.001 MI or LI versus cyclosporine ) . Belatacept patients experienced a higher incidence ( MI : 22 % , LI : 17 % and cyclosporine : 7 % ) and grade of acute rejection episodes . Safety was generally similar between groups , but posttransplant lymphoproliferative disorder was more common in the belatacept groups . Belatacept was associated with superior renal function and similar patient/graft survival versus cyclosporine at 1 year posttransplant , despite a higher rate of early acute rejection .
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Intervention_Pharmacological
belatacept-based immunosuppression regimens versus cyclosporine
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Intervention_Pharmacological
Belatacept
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Intervention_Pharmacological
calcineurin inhibitors
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Intervention_Pharmacological
belatacept
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Intervention_Pharmacological
cyclosporine
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Intervention_Pharmacological
belatacept
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Intervention_Pharmacological
cyclosporine :
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Intervention_Pharmacological
cyclosporine :
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Intervention_Pharmacological
cyclosporine )
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Intervention_Pharmacological
cyclosporine ;
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Intervention_Pharmacological
cyclosporine )
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Intervention_Pharmacological
cyclosporine :
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Intervention_Pharmacological
belatacept
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Intervention_Pharmacological
Belatacept
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Intervention_Pharmacological
cyclosporine
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Outcome_Physical
renal function
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Outcome_Mortality
patient/graft survival
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Outcome_Physical
composite renal impairment endpoint
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Outcome_Physical
incidence of acute rejection
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Outcome_Adverse-effects
patient/graft survival
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Outcome_Physical
superior renal function
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Outcome_Physical
composite renal impairment endpoint
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Outcome_Physical
mGFR
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Outcome_Physical
grade of acute rejection episodes
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Outcome_Other
Safety
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Outcome_Physical
renal function
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Outcome_Mortality
patient/graft survival
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Outcome_Physical
rate of early acute rejection
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Participant_Condition
renal transplant recipients
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Participant_Age
adults
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Participant_Condition
kidney transplant