糖尿病性腎症患者における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

NCT04750577

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

243

治験依頼者名

Boehringer Ingelheim

概要

This study is open to adults with diabetic kidney disease. The purpose of the study is to find out whether a medicine called BI 685509 improves kidney function. Three different doses of BI 685509 are tested in this study. Participants get either one of the three doses of BI 685509 or placebo. It is decided by chance who gets which BI 685509 dose and who gets placebo. Participants take BI 685509 or placebo as tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants continue taking their usual medicine for diabetes and 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 BI 685509 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 (12)