慢性腎臓病患者におけるアベンシグアト(BI 685509)の異なる投与量が腎機能に及ぼす影響を検証する研究
基本情報
- NCT ID
- NCT04736628
- ステータス
- 完了
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 261
- 治験依頼者名
- Boehringer Ingelheim
概要
This study is open to adults who have kidney disease that is not caused by diabetes. The purpose of the study is to find out whether a medicine called avenciguat (BI 685509) improves kidney function. Three different doses of avenciguat are tested in this study. Participants get either one of the three doses of avenciguat or placebo. It is decided by chance who gets which avenciguat dose and who gets placebo. Participants take avenciguat or placebo as tablets 3 times a day. Placebo tablets look like avenciguat tablets but do not contain any medicine. Participants continue taking their usual medicine for kidney disease throughout the study. Participants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Kidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of avenciguat and placebo. During the study, the doctors also regularly check the general health of the participants.
対象疾患
介入
依頼者(Sponsor)
実施施設 (15)
中山寺いまいクリニック
Hyogo, Takarazuka, Japan
Kuana City Medical Center
Mie, Kuwana, Japan
独立行政法人労働者健康安全機構 中部労災病院
Aichi, Nagoya, Japan
久留米大学病院
Fukuoka, Kurume, Japan
大同病院
Aichi, Nagoya, Japan
埼玉医科大学病院
Saitama, Iruma-gun, Japan
信州大学医学部附属病院
Nagano, Matsumoto, Japan
京都大学医学部附属病院
Kyoto, Kyoto, Japan
川崎医科大学附属病院
Okayama, Kurashiki, Japan
医療法人社団旭和会 東京駅センタービルクリニック
Tokyo, Chuo-ku, Japan
医療法人高井内科
Kanagawa, Kamakura, Japan
東京大学医学部附属病院
Tokyo, Bunkyo-ku, Japan
焼津市立総合病院
Shizuoka, Yaizu, Japan
学校法人日本大学 日本大学医学部附属板橋病院
Tokyo, Itabashi-ku, Japan
順天堂大学医学部附属浦安病院
Chiba, Urayasu, Japan