A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Chronic Kidney Disease Who do Not Have Diabetes
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|ClinicalTrials.gov Identifier: NCT04736628|
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : June 15, 2021
This study is open to adults who have kidney disease and do not have diabetes. 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 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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Drug: BI 685509 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomised, Double-blind (Within Dose Groups), Placebo Controlled and Parallel Group Trial to Investigate the Effects of Different Doses of Oral BI 685509 Given Over 20 Weeks on UACR Reduction in Patients With Non-diabetic Kidney Disease.|
|Actual Study Start Date :||April 27, 2021|
|Estimated Primary Completion Date :||July 19, 2022|
|Estimated Study Completion Date :||August 16, 2022|
Experimental: Dose group 1: BI 685509
Drug: BI 685509
Placebo Comparator: Dose group 1: Matching placebo
Matching placebo for low dose.
Experimental: Dose group 2: BI 685509
Low dose followed by up-titration to medium dose.
Drug: BI 685509
Placebo Comparator: Dose group 2: Matching placebo
Matching placebo for low dose followed by up-titration to medium dose.
Experimental: Dose group 3: BI 685509
Low dose followed by up-titration to medium dose, followed by up-titration to high-dose.
Drug: BI 685509
Placebo Comparator: Dose group 3: Matching placebo
Matching placebo for low dose followed by up-titration to medium dose, followed by up-titration to high dose.
- Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in 10-hour urine after 20 weeks of trial treatment. [ Time Frame: Up to 20 weeks ]
- Change from baseline in log transformed UACR measured in First Morning Void urine after 20 weeks of trial treatment. [ Time Frame: Up to 20 weeks ]
- Proportion of patients achieving UACR decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment. [ Time Frame: Up to 20 weeks ]
- Proportion of patients achieving UACR decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment. [ Time Frame: Up to 20 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04736628
|Contact: Boehringer Ingelheimfirstname.lastname@example.org|
|United States, Connecticut|
|Chase Medical Research, LLC||Recruiting|
|Waterbury, Connecticut, United States, 06708|
|Contact: Joseph Soufer +001 (203) 419-4420 email@example.com|
|United States, Florida|
|Indago Research and Health Center||Recruiting|
|Hialeah, Florida, United States, 33012|
|Contact: Jose Cardona +001 (305) 825-6588 firstname.lastname@example.org|
|United States, Texas|
|Texas Institute for Kidney and Endocrine Disorders||Recruiting|
|Lufkin, Texas, United States, 75904|
|Contact: Lance Sloan +001 (936) 414-3636 email@example.com|
|Australia, New South Wales|
|Renal Research, Gosford||Recruiting|
|Gosford, New South Wales, Australia, 2250|
|Contact: Simon Roger +61 2 4323 7977 firstname.lastname@example.org|
|Peking University First Hospital||Recruiting|
|Beijing, China, 100034|
|Contact: Minghui Zhao 13501243815 Zhaomh20212021@163.com|
|Tauranga, New Zealand, 3110|
|Contact: Katrina Allen +64 7 579 0453 KatrinaA@p3research.co.nz|
|P3 Research Waikanae||Recruiting|
|Waikanae, New Zealand, 5036|
|Contact: Nicola Pointing 64 4 908 1001 NicolaP@p3research.co.nz|
|Hospital Clínico de Valencia||Recruiting|
|Valencia, Spain, 46010|
|Contact: Jose Luis Gorriz Teruel +34961973811 email@example.com|
|Hospital Dr. Peset||Recruiting|
|Valencia, Spain, 46017|
|Contact: Veronica Escudero Quesada +34961622456 firstname.lastname@example.org|