🏥 治験ポータル
← 治験一覧に戻る

PODOMOUNT-Basket:BI 764198が様々なタイプの腎臓病を持つ成人および青年に効果があるかどうかを検証する研究

基本情報

NCT ID
NCT07355296
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
132
治験依頼者名
Boehringer Ingelheim

概要

This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions. Participants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group. Participants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

対象疾患

タンパク尿性腎疾患

介入

BI 764198(DRUG)
Placebo matching BI 764198(DRUG)

実施施設 (4)

東京女子医科大学病院

Tokyo, Shinjuku-ku, Japan

日本赤十字社愛知医療センター名古屋第二病院

Aichi, Nagoya, Japan

春日井市民病院

Aichi, Kasugai, Japan

東京慈恵会医科大学附属病院

Tokyo, Minato-ku, Japan