A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease
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
2 other identifiers
interventional
261
18 countries
110
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2021
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2021
CompletedFirst Posted
Study publicly available on registry
February 3, 2021
CompletedStudy Start
First participant enrolled
April 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2023
CompletedResults Posted
Study results publicly available
September 4, 2024
CompletedSeptember 4, 2024
August 1, 2024
2.3 years
February 1, 2021
August 8, 2024
August 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment
Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in 10-hour urine after 20 weeks of trial treatment is reported. Least Squares Mean (Standard error) were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12, and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient. Log transformed UACR at Week 20 was log of (average of all available scheduled measurements between week 18 and week 20). The data in the Outcome Measure Data Table represent the Least Squares Mean (Standard error) at Week 20.
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2, Week -1, Week 0 pre-dose) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.
Secondary Outcomes (3)
Change From Baseline in Log Transformed UACR Measured in First Morning Void Urine After 20 Weeks of Trial Treatment
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.
Number of Patients Achieving UACR Decreases in 10-hour Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment
At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.
Number of Patients Achieving UACR Decreases in First Morning Void Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment
At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.
Study Arms (4)
Avenciguat 1 mg TID
EXPERIMENTALTID=ter in die (3 times a day)
Avenciguat 2 mg TID
EXPERIMENTALAvenciguat 3 mg TID
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Avenciguat
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (110)
Clearview Medical Research, LLC
Canyon Country, California, 91351, United States
Rancho Cucamonga Clinical Trials
Rancho Cucamonga, California, 91730, United States
Kidney & Hypertension Center
Victorville, California, 92395, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Nephrology Associates, P.A.
Newark, Delaware, 19713, United States
Indago Research and Health Center
Hialeah, Florida, 33012, United States
Homestead Associates in Research
Miami, Florida, 33032, United States
Bioclinical Research Alliance, Inc.
Miami, Florida, 33155, United States
Alma Clinical Research, Inc.
Miami, Florida, 33165, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
Davita Clinical Research
Columbus, Georgia, 31904, United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406, United States
Boise Kidney and Hypertension, PLLC
Boise, Idaho, 83706, United States
Research by Design, LLC
Chicago, Illinois, 60643, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808, United States
DaVita Clinical Research
Las Vegas, Nevada, 89128, United States
Nevada Kidney Disease and Hypertension Centers, PLLC
Las Vegas, Nevada, 89128, United States
New Jersey Kidney Care, LLC
Jersey City, New Jersey, 07305, United States
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, 27103, United States
Knoxville Kidney Center PLLC
Knoxville, Tennessee, 37923, United States
Davita Clinical Research
El Paso, Texas, 79925, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212, United States
Kidney Specialists of North Houston, PLLC
Shenandoah, Texas, 77384, United States
STAT Research
CABA, C1023AAB, Argentina
CEDIC - Centro de Investigacion Clinica
CABA, C1060ABN, Argentina
CEMIC
CABA, C1431FWO, Argentina
Instituto Privado de Investigaciones Clínica Córdoba S.A.
Córdoba, X5000AAW, Argentina
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, B7600FYK, Argentina
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, B7600FZN, Argentina
Instituto Médico Catamarca - IMEC
Rosario, S2000AJU, Argentina
CEDIR Santa Fe
Santa Fe, S3000FSP, Argentina
CEREHA S.A.- Centro de Estudios Renales e Hipertensión Arterial
Sarandí, B1872EEB, Argentina
Renal Research, Gosford
Gosford, New South Wales, 2250, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Macquarie University
Macquarie Park, New South Wales, 2109, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
CARe Clinic
Red Deer, Alberta, T4P 1K4, Canada
Stouffville Medical Centre
Stouffville, Ontario, L4A 1H2, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Albion Finch Medical Centre
Toronto, Ontario, M9V 4B4, Canada
Fadia El Boreky Medicine Professional
Waterloo, Ontario, N2J 1C4, Canada
Peking University First Hospital
Beijing, 100034, China
Peking University People's Hospital
Beijing, 100044, China
Peking University Third Hospital
Beijing, 100191, China
People's Hospital of Sichuan Province
Chengdu, 610072, China
Second Affiliated Hospital Chongqing Medical University
Chongqing, 400016, China
The People's Hospital Of Xuancheng City
Xuancheng, 242000, China
Aarhus University Hospital
Aarhus N, 8200, Denmark
Herlev and Gentofte Hospital
Herlev, 2730, Denmark
Holbæk Sygehus
Holbæk, 4300, Denmark
Sjællands Universitetshospital
Roskilde, 4000, Denmark
Klinikum Region Hannover GmbH
Hanover, 30459, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538, Germany
Prince of Wales Hospital
Hong Kong, 999077, Hong Kong
Princess Margaret Hospital
Hong Kong, 999077, Hong Kong
Queen Mary Hospital
Hong Kong, 999077, Hong Kong
Tung Wah Hospital
Hong Kong, Hong Kong
Chubu Rosai Hospital
Aichi, Nagoya, 455-8530, Japan
Daido Hospital
Aichi, Nagoya, 457-8511, Japan
Juntendo University Urayasu Hospital
Chiba, Urayasu, 279-0021, Japan
Kurume University Hospital
Fukuoka, Kurume, 830-0011, Japan
Nakayamadera Imai Clinic
Hyogo, Takarazuka, 665-0861, Japan
Takai Naika Clinic
Kanagawa, Kamakura, 247-0056, Japan
Kyoto University Hospital
Kyoto, Kyoto, 606-8507, Japan
Kuana City Medical Center
Mie, Kuwana, 511-0061, Japan
Shinshu University Hospital
Nagano, Matsumoto, 390-8621, Japan
Kawasaki Medical School Hospital
Okayama, Kurashiki, 701-0192, Japan
Saitama Medical University Hospital
Saitama, Iruma-gun, 350-0495, Japan
Yaizu City Hospital
Shizuoka, Yaizu, 425-8505, Japan
The University of Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8655, Japan
Tokyo-Eki Center-building Clinic
Tokyo, Chuo-ku, 103-0027, Japan
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, 173-8610, Japan
University Kebangsaan Malaysia
Cheras, Kuala Lumpur, 56000, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30450, Malaysia
Universiti Sains Malaysia Hospital
Kelantan, 16150, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital Selayang
Kuala Selangor, 68100, Malaysia
Centro de Investigacion Cardiometabolica de Aguascalientes
Aguascalientes, 20230, Mexico
Centenario Hospital Miguel Hidalgo
Aguascalientes, 20259, Mexico
Instituto Nacional de Cs Médicas y Nutrición S Zubiran
Mexico City, 14000, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, 14080, Mexico
Clinstile S.A. de C.V.
México, 06700, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Dunedin Hospital
Dunedin, 9054, New Zealand
P3 Research Kapiti
Paraparaumu, 5032, New Zealand
P3 Research
Tauranga, 3110, New Zealand
Cardiovascular Centre of Malopolska
Chrzanów, 32-500, Poland
Pratia MCM Krakow
Krakow, 30-510, Poland
Cent.Clin.Hosp.Med.Univ.Lodz
Lodz, 92-213, Poland
Medicome Limited Liability Company
Oświęcim, 32600, Poland
ULS da Região de Aveiro
Aveiro, 3810-164, Portugal
CHLO, EPE - Hospital de Santa Cruz
Carnaxide, 2790-134, Portugal
ULS de Santa Maria, E.P.E
Lisbon, 1649-035, Portugal
Centro Hospitalar Universitário São João,EPE
Porto, 4200-319, Portugal
Moscow 1st State Med.Univ.n.a.I.M.Sechenov
Moscow, 119992, Russia
St. Petersburg GUZ City Hospital no. 31, St. Petersburg
Saint Petersburg, 197110, Russia
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
Clínica Universidad de Navarra
Pamplona, 31008, Spain
Hospital Virgen Macarena
Seville, 41009, Spain
Hospital Clínico de Valencia
Valencia, 46010, Spain
Hospital Dr. Peset
Valencia, 46017, Spain
ProbarE i Stockholm
Stockholm, 11329, Sweden
Lakeside Surgery
Corby, NN17 2UR, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Barts and The London School of Medicine and Dentistry
London, EC1M 6BQ, United Kingdom
Related Publications (1)
Heerspink HJL, Cherney D, Gafor AHA, Gorriz JL, Pergola PE, Tang SCW, Desch M, Iliev H, Sun Z, Steubl D, Nangaku M. Effect of Avenciguat on Albuminuria in Patients with CKD: Two Randomized Placebo-Controlled Trials. J Am Soc Nephrol. 2024 Sep 1;35(9):1227-1239. doi: 10.1681/ASN.0000000000000418. Epub 2024 May 25.
PMID: 38795055DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2021
First Posted
February 3, 2021
Study Start
April 27, 2021
Primary Completion
August 15, 2023
Study Completion
September 21, 2023
Last Updated
September 4, 2024
Results First Posted
September 4, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- 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 both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this 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". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to 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. The data shared are the raw clinical study data sets.