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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

Alport Syndrome

介入

BAY 3401016(BIOLOGICAL)
Placebo(OTHER)

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