A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease

Diabetic Nephropathies Clinical Trial

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 Diabetic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750577
• Other study ID #: 1366-0005
• Secondary ID: 2020-002929-28
• Status: Completed
• Phase: Phase 2
• Start date: April 27, 2021
• Est. completion date: December 27, 2022

Study information

• Verified date: November 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is open to adults with diabetic kidney disease. 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 diabetes and 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: December 27, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Signed and dated written informed consent in accordance with International Council of Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

2. Male or female patients aged = 18 years at time of consent.

3. 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.

4. Urine Albumin Creatinine Ratio (UACR) = 200 and < 3,500 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.

5. Treatment with the highest tolerated dose of either Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both together), and stable dose for = 4 weeks before Visit 1 with no planned change of the therapy during the trial.

6. 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 drug(s) (NSAIDs), endothelin receptor antagonists, systemic steroids or Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors.

7. Patients with stable type 1 or type 2 diabetes mellitus, diagnosed before informed consent. Treatment (including SGLT2 inhibitor and/or Glucagon-Like Peptide 1 (GLP1) receptor agonist) should have been unchanged or changes deemed minor (according to investigator's judgement) within 4 weeks before Visit 1 and until start of trial treatment.

8. Glycated Haemoglobin (HbA1c) < 10.0% at Visit 1 measured by the central laboratory.

Furhter inclusion criteria apply.

Exclusion criteria:

1. 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), NO donors including nitrates, sGC-stimulators/activators (other than trial treatment) or any other restricted medication (including OATP1B1/3 inhibitors, 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 are also excluded.

2. Any clinically relevant laboratory value from screening until start of trial treatment, which in the investigator's judgement puts the patient at additional risk.

3. Biopsy or otherwise confirmed non-diabetic chronic kidney disease, or non-diabetic chronic kidney disease in the opinion of investigator, e.g., Autosomal Dominant Polycystic Kidney Disease (ADPKD), uncontrolled lupus nephritis. The presence of a hypertensive etiology does not need to be excluded unless it is evident this is the only cause for the Chronic Kidney Disease (CKD).

4. Any immunosuppression therapy or immunotherapy in the last 3 months prior to visit 1 and throughout screening and baseline run-in (except prednisolone =10 mg or equivalent).

5. Acute kidney injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) in the 30 days prior to Visit 1 until the start of trial treatment.

6. Planned start of chronic renal replacement therapy during the trial or end stage renal disease before start of trial treatment.

7. Known history of moderate or severe symptomatic orthostatic dysregulation as judged by the investigator before start of trial treatment.

8. 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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases

Intervention

Other:
• Placebo matching BI 685509
film-coated tablet

Drug:
• BI 685509
film-coated tablet

Locations

Country	Name	City	State
Argentina	CEDIC - Centro de Investigacion Clinica	Caba
Argentina	Instituto Médico Especializado	Capital Federal
Argentina	Instituto Privado de Investigaciones Clínica Córdoba S.A.	Cordoba
Argentina	Centro de Investigaciones Médicas Mar del Plata	Mar del Plata
Argentina	Instituto Médico Catamarca - IMEC	Rosario
Argentina	CEREHA S.A.- Centro de Estudios Renales e Hipertensión Arterial	Sarandi
Australia	Renal Research, Gosford	Gosford	New South Wales
Australia	Austin Health	Heidelberg	Victoria
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	Macquarie University	Macquarie Park	New South Wales
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Canada	CARe Clinic	Red Deer	Alberta
Canada	Albion Finch Medical Centre	Toronto	Ontario
Canada	Fadia El Boreky Medicine Professional	Waterloo	Ontario
China	Peking University First Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	Second Affiliated Hospital Chongqing Medical University	Chongqing
China	People's Hospital of Sichuan Province	Sichuan
Denmark	Aarhus University Hospital	Aarhus N
Denmark	Steno Diabetes Center Copenhagen	Herlev
Denmark	Sjællands Universitetshospital	Roskilde
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Tung Wah Hospital	Hong Kong
Japan	Chubu Rosai Hospital	Aichi, Nagoya
Japan	Daido Hospital	Aichi, Nagoya
Japan	Kurume University Hospital	Fukuoka, Kurume
Japan	Nakayamadera Imai Clinic	Hyogo, Takarazuka
Japan	Takai Naika Clinic	Kanagawa, Kamakura
Japan	Kawasaki Medical School Hospital	Okayama, Kurashiki
Japan	Osaka General Medical Center	Osaka, Osaka
Japan	OCROM Clinic	Osaka, Suita
Japan	Saitama Medical University Hospital	Saitama, Iruma-gun
Japan	The University of Tokyo Hospital	Tokyo, Bunkyo-ku
Japan	Tokyo-Eki Center-building Clinic	Tokyo, Chuo-ku
Japan	ToCROM Clinic	Tokyo, Shinjyuku-ku
Malaysia	University Kebangsaan Malaysia	Cheras, Kuala Lumpur
Malaysia	Universiti Sains Malaysia Hospital	Kelantan
Malaysia	University of Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Selayang	Selangor
Mexico	Centenario Hospital Miguel Hidalgo	Aguascalientes
Mexico	Hospital Cardiologica Aguascalientes	Aguascalientes
Mexico	Clinstile S.A. de C.V.	México
Mexico	Hospital Universitario Dr Jose Eleuterio Gonzalez	Monterrey
Netherlands	Albert SchweitzerZiekenhuis	Dordrecht
Netherlands	Universitair Medisch Centrum Utrecht	GA Utrecht
New Zealand	P3 Research Kapiti	Paraparaumu
New Zealand	P3 Research	Tauranga
Poland	SPECDERM Poznanska General Partnership	Bialystok
Poland	Pratia MCM Krakow	Krakow
Poland	Medicome Limited Liability Company	Oswiecim
Poland	NBR Polska	Warsaw
Portugal	Centro Hospitalar do Baixo Vouga - Hospital Infante Dom Pedro	Aveiro
Portugal	APDP - Associação Protectora dos Diabéticos de Portugal	Lisboa
Spain	Hospital A Coruña	A Coruña
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Virgen Macarena	Sevilla
Spain	Hospital Clínico de Valencia	Valencia
United Kingdom	University Hospital Coventry	Coventry
United Kingdom	Barts and The London School of Medicine and Dentistry	London
United States	Total Renal Research	Bronx	New York
United States	Research by Design, LLC	Chicago	Illinois
United States	Davita Clinical Research	Columbus	Georgia
United States	Indago Research and Health Center	Hialeah	Florida
United States	DaVita Clinical Research	Houston	Texas
United States	Knoxville Kidney Center PLLC	Knoxville	Tennessee
United States	DaVita Clinical Research	Las Vegas	Nevada
United States	Texas Institute for Kidney and Endocrine Disorders	Lufkin	Texas
United States	Panax Clinical Research	Miami Lakes	Florida
United States	Tidewater Kidney Specialists	Norfolk	Virginia
United States	Clinical Advancement Center, PLLC	San Antonio	Texas
United States	DaVita Clinical Research	San Antonio	Texas
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Kidney Specialists of North Houston, PLLC	Shenandoah	Texas
United States	Kidney & Hypertension Center	Victorville	California
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Brookview Hills Research Associates LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  China,  Denmark,  Hong Kong,  Japan,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in 10-hour urine after 20 weeks of trial treatment		Up to 20 weeks.
Secondary	Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine after 20 weeks of trial treatment		Up to 20 weeks.
Secondary	Number of patients achieving UACR decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment		Up to 20 weeks.
Secondary	Number of patients achieving UACR decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment		Up to 20 weeks.

External Links

•   Related Info