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ベングルスタットによる常染色体優性多発性嚢胞腎(ADPKD)の長期治療
基本情報
- NCT ID
- NCT04705051
- ステータス
- 中止
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 24
- 治験依頼者名
- Sanofi
概要
Primary Objective: -To determine the effect of early versus delayed treatment with venglustat on the total kidney volume (TKV) in participants at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD). Secondary Objective: * To determine the effect of early versus delayed treatment with venglustat on the renal function (estimated glomerular filtration rate \[eGFR\] \[Chronic Kidney Disease Epidemiology Collaboration {CKD-EPI} equation\]). * To characterize the safety profile of venglustat. * To evaluate the effect of venglustat on the lens by ophthalmological examination. * To evaluate the effect of venglustat on mood using Beck Depression Inventory-II (BDI-II).
対象疾患
Congenital Cystic Kidney Disease
介入
Venglustat GZ402671(DRUG)
依頼者(Sponsor)
サノフィ株式会社(INDUSTRY)