A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Chronic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT04736628|
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : March 7, 2023
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This study is open to adults who have kidney disease that is not caused by 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 :||August 31, 2023|
|Estimated Study Completion Date :||September 30, 2023|
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Male or female patients aged ≥18 years at time of consent.
- Estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 20 and < 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis. eGFR must remain ≥20 mL/min/1.73 m2 after Visit 1 up to the start of Visit 3, measured by central or any local laboratory analysis.
- Urine albumin creatinine ratio (UACR) ≥ 200 and < 3,500 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.
- Patients with macroalbuminuria (>300 mg/g) should be treated with the highest tolerated dose of either Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both). For patients with microalbuminuria the use of ACEi or ARB is at the discretion of the Investigator. Treatment should be at a stable dose for ≥ 4 weeks before Visit 1 with no planned change of the therapy during the trial.
- If the patient is taking any of the following medications they should be on a stable dose at least 4 weeks prior to visit 1 until start of treatment, with no planned change of the therapy during the trial: anti-hypertensives, non-steroidal anti-inflammatory drugs (NSAIDs), endothelin receptor antagonists, systemic steroids or Sodium-glucose co-transporter-2 (SGLT2) inhibitors.
- In the Investigator's judgment any kind of diagnosed chronic kidney disease whose primary cause is clinically not considered to be of diabetic origin.
Further inclusion criteria apply
- Treatment with Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either ACEi or ARB), Phosphodiesterase-5-inhibitors, non-specific phosphodiesterase inhibitors (such as dipyridamole and theophylline), Nitric Oxide (NO) donors including nitrates, soluble Guanylate Cyclase (sGC)-stimulators/activators (other than trial treatment) or any other restricted medication (including Organic Anion-Transporting Polypeptide 1B1 and 1B3 (OATP1B1/3) inhibitors, Uridine 5'-diphosphate -glucuronosyltransferase (UGT) inhibitors/inducers) as provided in the Investigator Site File (ISF) within 4 weeks prior to visit 1 and throughout screening and baseline run-in. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Any clinically relevant laboratory value from screening until start of trial treatment which, in the investigator's judgement, puts the patient at additional risk.
- Diagnosed with diabetic kidney disease.
- Any immunosuppression therapy or immunotherapy in last 3 months prior to visit 1 and throughout screening and baseline run-in (except prednisolone ≤10 mg or equivalent).
- Acute kidney injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition in the 30 days prior to Visit 1 until the start of trial treatment.
- Planned start of chronic renal replacement therapy during the trial or end stage renal disease before start of trial treatment.
- Known history of moderate or severe symptomatic orthostatic dysregulation as judged by the investigator before start of trial treatment.
- The patient has an active infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (or is known to have a positive test from screening until randomisation).
- Further exclusion criteria apply
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|
|Responsible Party:||Boehringer Ingelheim|
|Other Study ID Numbers:||
2020-002930-33 ( EudraCT Number )
|First Posted:||February 3, 2021 Key Record Dates|
|Last Update Posted:||March 7, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.|
|Access Criteria:||For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Renal Insufficiency, Chronic