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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04750577
Ethics application status
Date submitted
9/02/2021
Date registered
11/02/2021

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
Treatment: Drugs - Placebo matching BI 685509
Treatment: Drugs - BI 685509

Placebo comparator: Placebo -

Experimental: BI 685509 1 mg TID -

Experimental: BI 685509 2 mg TID - Low dose followed by up-titration to medium dose.

Experimental: BI 685509 3 mg TID - Low dose followed by up-titration to medium dose, followed by up-titration to high-dose.


Treatment: Drugs: Placebo matching BI 685509
film-coated tablet

Treatment: Drugs: BI 685509
film-coated tablet
Intervention code [1] 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
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.
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
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.
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
Baseline (day -14 and -7) and week 20 (day 141).
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
Baseline (day -14 and -7) and week 20 (day 141).

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.

Further 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
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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
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Nevada
Country [7] 0 0
United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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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
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Canada
State/province [19] 0 0
Ontario
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China
State/province [20] 0 0
Beijing
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China
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Chongqing
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China
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Sichuan
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Denmark
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Aarhus N
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Denmark
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Herlev
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Denmark
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Roskilde
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Hong Kong
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Hong Kong
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Japan
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Aichi, Nagoya
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Japan
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Fukuoka, Kurume
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Japan
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Hyogo, Takarazuka
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Japan
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Kanagawa, Kamakura
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Japan
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Okayama, Kurashiki
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Japan
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Osaka, Osaka
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Japan
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Osaka, Suita
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Japan
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Saitama, Iruma-gun
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Japan
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Tokyo, Bunkyo-ku
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Japan
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Tokyo, Chuo-ku
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Japan
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Tokyo, Shinjyuku-ku
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Malaysia
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Cheras, Kuala Lumpur
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Malaysia
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Kelantan
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Malaysia
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Kuala Lumpur
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Malaysia
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Selangor
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Mexico
State/province [42] 0 0
Aguascalientes
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Mexico
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Monterrey
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Mexico
State/province [44] 0 0
México
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Netherlands
State/province [45] 0 0
Dordrecht
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Netherlands
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GA Utrecht
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New Zealand
State/province [47] 0 0
Paraparaumu
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New Zealand
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Tauranga
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Poland
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Bialystok
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Poland
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Krakow
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Poland
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Oswiecim
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Poland
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Warsaw
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Portugal
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Aveiro
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Portugal
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Lisboa
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Spain
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A Coruña
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Spain
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Barcelona
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Spain
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Sevilla
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Spain
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Once the criteria in section "Time Frame" are fulfilled, researchers can use the 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".

Furthermore, researchers can 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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Available to whom?
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 the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04750577