Randomised, Double-blind, Placebo-controlled and Parallel Dose Group Trial to Investigate Efficacy and Safety of Multiple Doses of Oral BI 690517 Over 14 Weeks, Alone and in Combination With Empagliflozin, in Patients With Diabetic and Non-diabetic Chronic Kidney Disease
Randomised, Double-blind, Placebo-controlled and Parallel Dose Group Trial to Investigate Efficacy and Safety of Multiple Doses of Oral BI 690517 Over 14 Weeks, Alone and in Combination With Empagliflozin, in Patients With Diabetic and Non-diabetic Chronic Kidney Disease
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.
Inclusion criteria
Additional inclusion criteria to be assessed before second randomisation (start of Treatment Period):
Exclusion criteria
Further criteria apply.
Albuquerque, New Mexico 87106, United States
CABA, C1060ABN, Argentina
Ciudad Autonoma Buenos Aires, C1430CKE, Argentina
Leuven/Vlaams-Brabant, 3000, Belgium
P. Faliro, 17562, Greece
Aichi, Ichinomiya, 491-8551, Japan
Aichi, Nagoya, 451-8511, Japan
Aichi, Nagoya, 454-0933, Japan
Aichi, Nagoya, 468-0009, Japan
Gumma, Takasaki, 370-0829, Japan
Nagano, Ina, 396-8555, Japan
Nagano, Suwa, 392-8510, Japan
Saitama, Kawagoe, 350-0851, Japan
Shiga, Omihachiman, 523-0082, Japan
Tokyo, Bunkyo-ku, 113-8655, Japan
Tokyo, Hachioji, 193-0998, Japan
Ueda, Nagano, 386-0407, Japan
Cheras, Kuala Lumpur, 56000, Malaysia
Nordbyhagen, 1478, Norway
Cheongiu, 28644, South Korea