BI 690517の異なる用量を単独またはエンパグリフロジンとの併用で投与した場合、慢性腎臓病患者の腎機能が改善するかどうかを検証する研究

基本情報

NCT ID

NCT05182840

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

714

治験依頼者名

Boehringer Ingelheim

概要

This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study. The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin. In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine. In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 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. Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.

対象疾患

介入

依頼者（Sponsor）

実施施設 (14)