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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04750577




Registration number
NCT04750577
Ethics application status
Date submitted
9/02/2021
Date registered
11/02/2021
Date last updated
28/11/2023

Titles & IDs
Public title
A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease
Scientific 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
Secondary ID [1] 0 0
2020-002929-28
Secondary ID [2] 0 0
1366-0005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Nephropathies 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Placebo matching BI 685509
Treatment: Drugs - BI 685509

Placebo Comparator: Placebo -

Experimental: Dose group 1: BI 685509 - Low dose

Experimental: Dose group 2: BI 685509 - 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.


Other interventions: Placebo matching BI 685509
film-coated tablet

Treatment: Drugs: BI 685509
film-coated tablet
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in 10-hour urine after 20 weeks of trial treatment
Timepoint [1] 0 0
Up to 20 weeks.
Secondary outcome [1] 0 0
Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine after 20 weeks of trial treatment
Timepoint [1] 0 0
Up to 20 weeks.
Secondary outcome [2] 0 0
Number of patients achieving UACR decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment
Timepoint [2] 0 0
Up to 20 weeks.
Secondary outcome [3] 0 0
Number of patients achieving UACR decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment
Timepoint [3] 0 0
Up to 20 weeks.

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/12/2022
Sample size
Target
Accrual to date
Final
243
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Renal Research, Gosford - Gosford
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Argentina
State/province [12] 0 0
Caba
Country [13] 0 0
Argentina
State/province [13] 0 0
Capital Federal
Country [14] 0 0
Argentina
State/province [14] 0 0
Cordoba
Country [15] 0 0
Argentina
State/province [15] 0 0
Mar del Plata
Country [16] 0 0
Argentina
State/province [16] 0 0
Rosario
Country [17] 0 0
Argentina
State/province [17] 0 0
Sarandi
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
China
State/province [20] 0 0
Beijing
Country [21] 0 0
China
State/province [21] 0 0
Chongqing
Country [22] 0 0
China
State/province [22] 0 0
Sichuan
Country [23] 0 0
Denmark
State/province [23] 0 0
Aarhus N
Country [24] 0 0
Denmark
State/province [24] 0 0
Herlev
Country [25] 0 0
Denmark
State/province [25] 0 0
Roskilde
Country [26] 0 0
Hong Kong
State/province [26] 0 0
Hong Kong
Country [27] 0 0
Japan
State/province [27] 0 0
Aichi, Nagoya
Country [28] 0 0
Japan
State/province [28] 0 0
Fukuoka, Kurume
Country [29] 0 0
Japan
State/province [29] 0 0
Hyogo, Takarazuka
Country [30] 0 0
Japan
State/province [30] 0 0
Kanagawa, Kamakura
Country [31] 0 0
Japan
State/province [31] 0 0
Okayama, Kurashiki
Country [32] 0 0
Japan
State/province [32] 0 0
Osaka, Osaka
Country [33] 0 0
Japan
State/province [33] 0 0
Osaka, Suita
Country [34] 0 0
Japan
State/province [34] 0 0
Saitama, Iruma-gun
Country [35] 0 0
Japan
State/province [35] 0 0
Tokyo, Bunkyo-ku
Country [36] 0 0
Japan
State/province [36] 0 0
Tokyo, Chuo-ku
Country [37] 0 0
Japan
State/province [37] 0 0
Tokyo, Shinjyuku-ku
Country [38] 0 0
Malaysia
State/province [38] 0 0
Cheras, Kuala Lumpur
Country [39] 0 0
Malaysia
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Kelantan
Country [40] 0 0
Malaysia
State/province [40] 0 0
Kuala Lumpur
Country [41] 0 0
Malaysia
State/province [41] 0 0
Selangor
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Mexico
State/province [42] 0 0
Aguascalientes
Country [43] 0 0
Mexico
State/province [43] 0 0
Monterrey
Country [44] 0 0
Mexico
State/province [44] 0 0
México
Country [45] 0 0
Netherlands
State/province [45] 0 0
Dordrecht
Country [46] 0 0
Netherlands
State/province [46] 0 0
GA Utrecht
Country [47] 0 0
New Zealand
State/province [47] 0 0
Paraparaumu
Country [48] 0 0
New Zealand
State/province [48] 0 0
Tauranga
Country [49] 0 0
Poland
State/province [49] 0 0
Bialystok
Country [50] 0 0
Poland
State/province [50] 0 0
Krakow
Country [51] 0 0
Poland
State/province [51] 0 0
Oswiecim
Country [52] 0 0
Poland
State/province [52] 0 0
Warsaw
Country [53] 0 0
Portugal
State/province [53] 0 0
Aveiro
Country [54] 0 0
Portugal
State/province [54] 0 0
Lisboa
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Spain
State/province [55] 0 0
A Coruña
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Spain
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Barcelona
Country [57] 0 0
Spain
State/province [57] 0 0
Sevilla
Country [58] 0 0
Spain
State/province [58] 0 0
Valencia
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Coventry
Country [60] 0 0
United Kingdom
State/province [60] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04750577
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04750577