慢性腎不全用剤の海外における第３相臨床試験について

2012 ೥ 10݄10 ೔ Ґ ໊
ࣾ ΫϨϋ ௕
খ ྛ
๛ ߸ ̐̌̎̏ʢ౦ূୈҰ෦ʣ ͤઌ ใɾ̧̞෦௕
਺ Ҫ ໌ੜ

ʢ̡̩̚
̌̏ʵ̏̎̐̕ʵ̐̒̑̍ʣ ͷւ֎ʹ͓͚Δୈ 3ʹ͍ͭͯ ʮΫϨϝδϯʯ ͷւ֎ʹ͓͚Δ ୈ 3ͷͱ͓Γ͓஌Β͍ͤͨ͠·͢ɻ ʹΑΔ 2013 ೥ 3੷༧૝ʢ2012 ೥ 8݄2ඍͰ͢ɻ ͕ 2012 ೥ 1݄23ըʮGrow Globally -ᶘʯʹ͓͚Δఆྔ ͕
ʹ͸଎΍͔ʹ͓஌Β͍ͤͨ͠·͢ɻ Ҏ্ ʥ 2012 ೥ 10݄10 ೔ Ґ ࣾ ࣾ Ϋ Ϩ ϋ ͷւ֎ʹ͓͚Δୈ 3ʹ͍ͭͯ ௕ɿ౔԰ ඛ੡ༀzʣͱ ௕ɿখྛ ๛ɺ ҎԼ lΫϨϋzʣ ͸ɺ ΫϨϋ͕૑੡͠ɺ ࡎ ։ൃίʔυɿAST-120ࡾ ඛ੡ༀͷ։ൃίʔυ ʮMP-146ͨ͠ୈ 3ʢEPPICˎ1ʣ͕ऴྃ͠·ͨ͠ͷͰ͓஌Β͍ͤͨ͠·͢ɻ ͸ɺԤถΛத৺ʹɺ໿ 2,000͞Ε·ͨ͠ˎ2ɻ ऀΛର ৅ʹ AST-120 9gˎ3 Λ෰༻ͨ͠ AST-120ʹ͍ͭͯɺ Πϕ ໨ͱ͠ ౼͍ͨ͠·ͨ͠ɻ ໨ʹ͓͍ͯ AST-120͸ ऀάϧʔ ੑ͕ೝΊΒΕ͍ͯ·͢ɻ Ұํɺ҆શੑʹ͍ͭͯ͸ AST-120ೝ͞Ε·ͨ͠ɻ
ͷৄ͍͠಺༰͸ɺຊ೥ 11݄3ձ(ASN)Ͱൃද͞ΕΔ ༧ఆͰ͢ɻ Ҏ
্ ˎ̍ɿEPPICཁʹ͍ͭͯ Evaluating Prevention of Progression In Chronic Kidney Disease ͠ɺ2007ઃ ɻ ऀ໿ 2,000 ໊ ࣮ ࢪ ɿ๺ถɺϥςϯΞϝϦΧɺϤʔϩούͷ 13ࠃ ઃ਺ɿ໿ 240ઃ ɿ3.5 ೥ ݧࢼֱ ໨ɿ Τϯυ ϙΠϯτ



໨ʙeGFR ͷมԽ཰౳ ͸ɺ೔ຊͰͷୈ 3౓ͱΫ ϨΞνχϯ஋͕ҟͳΔ΋ͷͰͨ͠ɻ ˎ̏ ɿʮΫϨϝδϯʯͷ 1 ೔ 9g಺ঝೝ༻ྔ 6gʣɻ ʳ ʮΫϨϝδϯʯʹ͍ͭͯ ੜ͞ ண͠ɺศͱͱ΋ʹମ֎ʹഉᔔ͢Δɻ͜ͷ͜ ຫੑਛෆ ಺ʹ͓͍ͯ͸ 1991ͨΔ஍ҐΛங͍͍ͯ·͢ɻ Θͤઌʼ ใ෦
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