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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

Chronic Kidney Disease

介入

Avenciguat(DRUG)
Placebo(DRUG)

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