BAY3401016;バイオマーカー研究アルポート
基本情報
- NCT ID
- NCT07211685
- ステータス
- 募集前
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 60
- 治験依頼者名
- Bayer
概要
Alport syndrome (AS) is a rare genetic condition that causes kidney disease, hearing loss, and eye abnormalities that occur due to changes in specific genes (COL4A3, COL4A4, and COL4A5). These genes help in producing an important protein called collagen. People with AS have a high risk of developing chronic kidney disease (CKD), a condition in which there is progressive loss in kidney function over time. The kidneys soon lose their ability to remove waste products from the body properly, resulting in end-stage kidney disease. A common sign of decreasing kidney function is the presence of excess protein in the urine that is not usually found with healthy kidneys. This condition is known as proteinuria. The study drug, BAY 3401016 (a monoclonal antibody), is a type of medicine that blocks a protein called Semaphorin 3A (Sema3A), which is thought to be involved in causing kidney damage in AS. By blocking the action of the Sema3A protein, BAY 3401016 may prevent proteinuria and slow down the loss in kidney function due to AS. The main purpose of this study is to learn more about how well BAY 3401016 works in slowing down the loss in kidney function in adults with a rapidly progressing AS.
対象疾患
介入
依頼者(Sponsor)
実施施設 (4)
日本赤十字社愛知医療センター名古屋第二病院
Nagoya, Aichi-ken, Japan
地方独立行政法人 大阪府立病院機構 大阪国際がんセンター
Osaka, Japan
Saitama Prefectural Children's Medical Center
Chuo-Ku, Saitama, Japan
神戸大学医学部附属病院
Kobe, Japan