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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04750577

Collaborator

(none)

238

Enrollment

Locations

Arms

Anticipated Duration (Months)

3.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathies	Other: Placebo Drug: BI 685509	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

238 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multicentre, randomised, double-blind (within dose groups), parallel, placebo-controlled trial. Patients will be randomised equally into one of three parallel dose groups, and in each dose group to treatment either with BI 685509 or matching placebo in a 3:1 ratio.Multicentre, randomised, double-blind (within dose groups), parallel, placebo-controlled trial. Patients will be randomised equally into one of three parallel dose groups, and in each dose group to treatment either with BI 685509 or matching placebo in a 3:1 ratio.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 27, 2021

Anticipated Primary Completion Date :

Dec 2, 2022

Anticipated Study Completion Date :

Dec 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose group 1: BI 685509 Low dose.	Drug: BI 685509 BI 685509
Placebo Comparator: Dose group 1: Matching placebo Matching placebo for low dose.	Other: Placebo Matching placebo
Experimental: Dose group 2: BI 685509 Low dose followed by up-titration to medium dose.	Drug: BI 685509 BI 685509
Placebo Comparator: Dose group 2: Matching placebo Matching placebo for low dose followed by up-titration to medium dose.	Other: Placebo Matching placebo
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 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.	Other: Placebo Matching placebo

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Change from baseline in log transformed UACR measured in First Morning Void urine after 20 weeks of trial treatment [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 [Up to 20 weeks.]
Proportion of patients achieving UACR decreases in First Morning Void urine of at least 20% form baseline after 20 weeks of trial treatment [Up to 20 weeks.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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.
Male or female patients aged ≥ 18 years at time of consent.
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.
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.
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.
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.
Glycated Haemoglobin (HbA1c) < 10.0% at Visit 1 measured by the central laboratory.

Furhter inclusion criteria apply.

Exclusion criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kidney & Hypertension Center	Victorville	California	United States	92395
2	Chase Medical Research, LLC	Waterbury	Connecticut	United States	06708
3	Indago Research and Health Center	Hialeah	Florida	United States	33012
4	Panax Clinical Research	Miami Lakes	Florida	United States	33014
5	Davita Clinical Research	Columbus	Georgia	United States	31904
6	Meridian Clinical Research, LLC	Savannah	Georgia	United States	31406
7	Research by Design, LLC	Chicago	Illinois	United States	60643
8	DaVita Clinical Research	Las Vegas	Nevada	United States	89128
9	Total Renal Research	Bronx	New York	United States	10461
10	Brookview Hills Research Associates LLC	Winston-Salem	North Carolina	United States	27103
11	Knoxville Kidney Center PLLC	Knoxville	Tennessee	United States	37923
12	DaVita Clinical Research	Houston	Texas	United States	77054
13	Texas Institute for Kidney and Endocrine Disorders	Lufkin	Texas	United States	75904
14	Clinical Advancement Center, PLLC	San Antonio	Texas	United States	78212
15	Davita Clinical Research	San Antonio	Texas	United States	78258
16	Kidney Specialists of North Houston, PLLC	Shenandoah	Texas	United States	77384
17	Tidewater Kidney Specialists	Norfolk	Virginia	United States	23510
18	CEDIC - Centro de Investigacion Clinica	Caba		Argentina	C1060ABN
19	Instituto Médico Especializado	Capital Federal		Argentina	C1405BCH
20	Instituto Privado de Investigaciones Clínica Córdoba S.A.	Cordoba		Argentina	X5000AAW
21	Centro de Investigaciones Médicas	Mar del Plata		Argentina	B7600FYK
22	Instituto Médico Catamarca - IMEC	Rosario		Argentina	S2000AJU
23	CEREHA S.A.- Centro de Estudios Renales e Hipertensión Arterial	Sarandi		Argentina	B1872EEB
24	Renal Research, Gosford	Gosford	New South Wales	Australia	2250
25	Nepean Hospital	Kingswood	New South Wales	Australia	2747
26	Macquarie University	Macquarie Park	New South Wales	Australia	2109
27	Royal North Shore Hospital	St Leonards	New South Wales	Australia	2065
28	Westmead Hospital	Westmead	New South Wales	Australia	2145
29	Austin Health	Heidelberg	Victoria	Australia	3084
30	CARe Clinic	Red Deer	Alberta	Canada	T4P 1K4
31	Albion Finch Medical Centre	Toronto	Ontario	Canada	M9V 4B4
32	Fadia El Boreky Medicine Professional	Waterloo	Ontario	Canada	N2J 1C4
33	Peking University First Hospital	Beijing		China	100034
34	Peking University Third Hospital	Beijing		China	100191
35	Second Affiliated Hospital Chongqing Medical University	Chongqing		China	400016
36	People's Hospital of Sichuan Province	Sichuan		China	610031
37	Aarhus University Hospital	Aarhus N		Denmark	8200
38	Steno Diabetes Center Copenhagen	Herlev		Denmark	2730
39	Sjællands Universitetshospital	Roskilde		Denmark	4000
40	Prince of Wales Hospital	Hong Kong		Hong Kong	999077
41	Queen Mary Hospital	Hong Kong		Hong Kong	999077
42	Tung Wah Hospital	Hong Kong		Hong Kong	999077
43	Chubu Rosai Hospital	Aichi, Nagoya		Japan	455-8530
44	Daido Hospital	Aichi, Nagoya		Japan	457-8511
45	Kurume University Hospital	Fukuoka, Kurume		Japan	830-0011
46	Nakayamadera Imai Clinic	Hyogo, Takarazuka		Japan	665-0861
47	Takai Naika Clinic	Kanagawa, Kamakura		Japan	247-0056
48	Kawasaki Medical School Hospital	Okayama, Kurashiki		Japan	701-0192
49	Osaka General Medical Center	Osaka, Osaka		Japan	558-8558
50	OCROM Clinic	Osaka, Suita		Japan	565-0853
51	Saitama Medical University Hospital	Saitama, Iruma-gun		Japan	350-0495
52	The University of Tokyo Hospital	Tokyo, Bunkyo-ku		Japan	113-8655
53	Tokyo-Eki Center-building Clinic	Tokyo, Chuo-ku		Japan	103-0027
54	ToCROM Clinic	Tokyo, Shinjyuku-ku		Japan	160-0008
55	University Kebangsaan Malaysia	Cheras, Kuala Lumpur		Malaysia	56000
56	Universiti Sains Malaysia Hospital	Kelantan		Malaysia	16150
57	University of Malaya Medical Centre	Kuala Lumpur		Malaysia	59100
58	Hospital Selayang	Selangor		Malaysia	68100
59	Hospital Cardiologica Aguascalientes	Aguascalientes		Mexico	20230
60	Centenario Hospital Miguel Hidalgo	Aguascalientes		Mexico	20259
61	Hospital Universitario Dr Jose Eleuterio Gonzalez	Monterrey		Mexico	64460
62	Clinstile S.A. de C.V.	México		Mexico	06700
63	Albert SchweitzerZiekenhuis	Dordrecht		Netherlands	3318 AT
64	Universitair Medisch Centrum Utrecht	GA Utrecht		Netherlands	3508
65	P3 Research Kapiti	Paraparaumu		New Zealand	5032
66	P3 Research	Tauranga		New Zealand	3110
67	SPECDERM Poznanska General Partnership	Bialystok		Poland	15-375
68	Medical Center Malopolskie S.C., Krakow	Krakow		Poland	30-510
69	Medicome Limited Liability Company	Oswiecim		Poland	32-600
70	NBR Polska	Warsaw		Poland	00-465
71	Centro Hospitalar do Baixo Vouga - Hospital Infante Dom Pedro	Aveiro		Portugal	3810-164
72	APDP - Associação Protectora dos Diabéticos de Portugal	Lisboa		Portugal	1250-189
73	Hospital A Coruña	A Coruña		Spain	15006
74	Hospital Vall d'Hebron	Barcelona		Spain	08035
75	Hospital Virgen Macarena	Sevilla		Spain	41009
76	Hospital Clínico de Valencia	Valencia		Spain	46010
77	University Hospital Coventry	Coventry		United Kingdom	CV2 2DX
78	Barts and The London School of Medicine and Dentistry	London		United Kingdom	EC1M 6BQ

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT04750577

Other Study ID Numbers:

1366-0005
2020-002929-28

First Posted:

Feb 11, 2021

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Diabetic Nephropathies

Study Results

No Results Posted as of Aug 25, 2022