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慢性腎臓病(CKD)に伴う貧血を有する日本人血液透析(HD)患者におけるダプロデュスタットとダルベポエチンアルファの有効性および安全性を評価する研究
基本情報
- NCT ID
- NCT02969655
- ステータス
- 完了
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 271
- 治験依頼者名
- GlaxoSmithKline
概要
Daprodustat is a drug that is currently being developed as a treatment for renal anemia . This study is to evaluate the efficacy and safety of daprodustat following a switch from erythropoiesis-stimulating agent (ESA) in Japanese HD subjects with renal anemia who are currently treated with ESA. The primary objective is to demonstrate non-inferiority of daprodustat to darbepoetin alfa. This study is a 52-week, Phase III, double-blind, active-controlled, parallel-group, multi-center study. The total duration of the study will be approximately 58 weeks including screening and follow-up.
対象疾患
Anaemia
介入
Daprodustat small(DRUG)
Daprodustat small placebo(DRUG)
Daprodustat large(DRUG)
Daprodustat large placebo(DRUG)
Darbepoetin alfa(DRUG)
Darbepoetin alfa placebo(DRUG)
依頼者(Sponsor)
グラクソ・スミスクライン株式会社(INDUSTRY)