Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04736628
Registration number
NCT04736628
Ethics application status
Date submitted
1/02/2021
Date registered
3/02/2021
Date last updated
7/05/2024
Titles & IDs
Public title
A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease
Query!
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 Non-diabetic Kidney Disease
Query!
Secondary ID [1]
0
0
2020-002930-33
Query!
Secondary ID [2]
0
0
1366-0022
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Kidney disease
Query!
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Avenciguat
Treatment: Drugs - Placebo
Experimental: Dose group 1: Avenciguat - Low dose.
Placebo Comparator: Dose group 1: Matching placebo - Matching placebo for low dose.
Experimental: Dose group 2: Avenciguat - Low dose followed by up-titration to medium dose.
Placebo Comparator: Dose group 2: Matching placebo - Matching placebo for low dose followed by up-titration to medium dose.
Experimental: Dose group 3: Avenciguat - Low dose followed by up-titration to medium dose, followed by up-titration to high-dose.
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.
Treatment: Drugs: Avenciguat
Avenciguat
Treatment: Drugs: Placebo
Placebo
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
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.
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Up to 20 weeks
Query!
Secondary outcome [1]
0
0
Change from baseline in log transformed UACR measured in First Morning Void urine after 20 weeks of trial treatment.
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Up to 20 weeks
Query!
Secondary outcome [2]
0
0
Proportion of patients achieving UACR decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment.
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Up to 20 weeks
Query!
Secondary outcome [3]
0
0
Proportion of patients achieving UACR decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment.
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Up to 20 weeks
Query!
Eligibility
Key inclusion criteria
- 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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), 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
27/04/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
21/09/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
261
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Renal Research, Gosford - Gosford
Query!
Recruitment hospital [2]
0
0
Nepean Hospital - Kingswood
Query!
Recruitment hospital [3]
0
0
Macquarie University - Macquarie Park
Query!
Recruitment hospital [4]
0
0
Royal North Shore Hospital - St Leonards
Query!
Recruitment hospital [5]
0
0
Westmead Hospital - Westmead
Query!
Recruitment hospital [6]
0
0
Austin Health - Heidelberg
Query!
Recruitment hospital [7]
0
0
Royal Melbourne Hospital - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2250 - Gosford
Query!
Recruitment postcode(s) [2]
0
0
2747 - Kingswood
Query!
Recruitment postcode(s) [3]
0
0
2109 - Macquarie Park
Query!
Recruitment postcode(s) [4]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [5]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [6]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [7]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Delaware
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Idaho
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Nevada
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New Jersey
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
North Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Tennessee
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Caba
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Cordoba
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Mar del Plata
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Rosario
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Santa Fe
Query!
Country [19]
0
0
Argentina
Query!
State/province [19]
0
0
Sarandi
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Alberta
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Ontario
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Beijing
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Chengdu
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Chongqing
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Xuancheng
Query!
Country [26]
0
0
Denmark
Query!
State/province [26]
0
0
Aarhus N
Query!
Country [27]
0
0
Denmark
Query!
State/province [27]
0
0
Herlev
Query!
Country [28]
0
0
Denmark
Query!
State/province [28]
0
0
Holbæk
Query!
Country [29]
0
0
Denmark
Query!
State/province [29]
0
0
Roskilde
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Hannover
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Lübeck
Query!
Country [32]
0
0
Hong Kong
Query!
State/province [32]
0
0
Hong Kong
Query!
Country [33]
0
0
Japan
Query!
State/province [33]
0
0
Aichi, Nagoya
Query!
Country [34]
0
0
Japan
Query!
State/province [34]
0
0
Chiba, Urayasu
Query!
Country [35]
0
0
Japan
Query!
State/province [35]
0
0
Fukuoka, Kurume
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Hyogo, Takarazuka
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Kanagawa, Kamakura
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Kyoto, Kyoto
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Mie, Kuwana
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Nagano, Matsumoto
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Okayama, Kurashiki
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Saitama, Iruma-gun
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Shizuoka, Yaizu
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Tokyo, Bunkyo-ku
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Tokyo, Chuo-ku
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Tokyo, Itabashi-ku
Query!
Country [47]
0
0
Malaysia
Query!
State/province [47]
0
0
Cheras, Kuala Lumpur
Query!
Country [48]
0
0
Malaysia
Query!
State/province [48]
0
0
Ipoh, Perak
Query!
Country [49]
0
0
Malaysia
Query!
State/province [49]
0
0
Kelantan
Query!
Country [50]
0
0
Malaysia
Query!
State/province [50]
0
0
Kuala Lumpur
Query!
Country [51]
0
0
Malaysia
Query!
State/province [51]
0
0
Selangor
Query!
Country [52]
0
0
Mexico
Query!
State/province [52]
0
0
Aguascalientes
Query!
Country [53]
0
0
Mexico
Query!
State/province [53]
0
0
Ciudad de Mexico
Query!
Country [54]
0
0
Mexico
Query!
State/province [54]
0
0
Ciudad de México
Query!
Country [55]
0
0
Mexico
Query!
State/province [55]
0
0
Monterrey
Query!
Country [56]
0
0
Mexico
Query!
State/province [56]
0
0
México
Query!
Country [57]
0
0
New Zealand
Query!
State/province [57]
0
0
Dunedin
Query!
Country [58]
0
0
New Zealand
Query!
State/province [58]
0
0
Paraparaumu
Query!
Country [59]
0
0
New Zealand
Query!
State/province [59]
0
0
Tauranga
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Chrzanow
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Krakow
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Lodz
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Oswiecim
Query!
Country [64]
0
0
Portugal
Query!
State/province [64]
0
0
Aveiro
Query!
Country [65]
0
0
Portugal
Query!
State/province [65]
0
0
Carnaxide
Query!
Country [66]
0
0
Portugal
Query!
State/province [66]
0
0
Lisboa
Query!
Country [67]
0
0
Portugal
Query!
State/province [67]
0
0
Porto
Query!
Country [68]
0
0
Russian Federation
Query!
State/province [68]
0
0
Moscow
Query!
Country [69]
0
0
Russian Federation
Query!
State/province [69]
0
0
St. Petersburg
Query!
Country [70]
0
0
Spain
Query!
State/province [70]
0
0
Barcelona
Query!
Country [71]
0
0
Spain
Query!
State/province [71]
0
0
L'Hospitalet de Llobregat
Query!
Country [72]
0
0
Spain
Query!
State/province [72]
0
0
Madrid
Query!
Country [73]
0
0
Spain
Query!
State/province [73]
0
0
Pamplona
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Sevilla
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
Valencia
Query!
Country [76]
0
0
Sweden
Query!
State/province [76]
0
0
Stockholm
Query!
Country [77]
0
0
United Kingdom
Query!
State/province [77]
0
0
Corby
Query!
Country [78]
0
0
United Kingdom
Query!
State/province [78]
0
0
Coventry
Query!
Country [79]
0
0
United Kingdom
Query!
State/province [79]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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 avenciguat (BI 685509) improves
kidney function. Three different doses of avenciguat are tested in this study.
Participants get either one of the three doses of avenciguat or placebo. It is decided by
chance who gets which avenciguat dose and who gets placebo. Participants take avenciguat or
placebo as tablets 3 times a day. Placebo tablets look like avenciguat 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 avenciguat and placebo. During the study, the doctors also regularly check the general
health of the participants.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04736628
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04736628
Download to PDF