Chronic Kidney DiseasePhase 2NCT04736628
A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease
A Phase 2 study testing Avenciguat in people with Chronic Kidney Disease, run by Boehringer Ingelheim at 110 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Avenciguat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 261 participants
- Where
- 110 sitesin 18 countries
- Study dates
- 27 Apr 2021to 21 Sep 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
110 sites in 18 countries.
110 sites in 18 countries
United States23 sites
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808
Boise Kidney and Hypertension, PLLC
Boise, Idaho, 83706
Clearview Medical Research, LLC
Canyon Country, California, 91351
Research by Design, LLC
Chicago, Illinois, 60643
Davita Clinical Research
Columbus, Georgia, 31904
Davita Clinical Research
El Paso, Texas, 79925
Indago Research and Health Center
Hialeah, Florida, 33012
New Jersey Kidney Care, LLC
Jersey City, New Jersey, 07305
Knoxville Kidney Center PLLC
Knoxville, Tennessee, 37923
DaVita Clinical Research
Las Vegas, Nevada, 89128
Nevada Kidney Disease and Hypertension Centers, PLLC
Las Vegas, Nevada, 89128
Homestead Associates in Research
Miami, Florida, 33032
Bioclinical Research Alliance, Inc.
Miami, Florida, 33155
Alma Clinical Research, Inc.
Miami, Florida, 33165
Panax Clinical Research
Miami Lakes, Florida, 33014
Nephrology Associates, P.A.
Newark, Delaware, 19713
Rancho Cucamonga Clinical Trials
Rancho Cucamonga, California, 91730
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
Kidney Specialists of North Houston, PLLC
Shenandoah, Texas, 77384
Kidney & Hypertension Center
Victorville, California, 92395
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, 27103
Japan15 sites
Chubu Rosai Hospital
Aichi, Nagoya, 455-8530
Daido Hospital
Aichi, Nagoya, 457-8511
Juntendo University Urayasu Hospital
Chiba, Urayasu, 279-0021
Kurume University Hospital
Fukuoka, Kurume, 830-0011
Nakayamadera Imai Clinic
Hyogo, Takarazuka, 665-0861
Takai Naika Clinic
Kanagawa, Kamakura, 247-0056
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Kuana City Medical Center
Mie, Kuwana, 511-0061
Shinshu University Hospital
Nagano, Matsumoto, 390-8621
Kawasaki Medical School Hospital
Okayama, Kurashiki, 701-0192
Saitama Medical University Hospital
Saitama, Iruma-gun, 350-0495
Yaizu City Hospital
Shizuoka, Yaizu, 425-8505
The University of Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8655
Tokyo-Eki Center-building Clinic
Tokyo, Chuo-ku, 103-0027
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, 173-8610
Argentina9 sites
STAT Research
CABA, C1023AAB
CEDIC - Centro de Investigacion Clinica
CABA, C1060ABN
CEMIC
CABA, C1431FWO
Instituto Privado de Investigaciones Clínica Córdoba S.A.
Córdoba, X5000AAW
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, B7600FYK
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, B7600FZN
Instituto Médico Catamarca - IMEC
Rosario, S2000AJU
CEDIR Santa Fe
Santa Fe, S3000FSP
CEREHA S.A.- Centro de Estudios Renales e Hipertensión Arterial
Sarandí, B1872EEB
Australia7 sites
Renal Research, Gosford
Gosford, New South Wales, 2250
Austin Health
Heidelberg, Victoria, 3084
Nepean Hospital
Kingswood, New South Wales, 2747
Macquarie University
Macquarie Park, New South Wales, 2109
Royal Melbourne Hospital
Parkville, Victoria, 3050
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Westmead Hospital
Westmead, New South Wales, 2145
Spain7 sites
Hospital Vall d'Hebron
Barcelona, 08035
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907
Fundación Jiménez Díaz
Madrid, 28040
Clínica Universidad de Navarra
Pamplona, 31008
Hospital Virgen Macarena
Seville, 41009
Hospital Clínico de Valencia
Valencia, 46010
Hospital Dr. Peset
Valencia, 46017
China6 sites
Peking University First Hospital
Beijing, 100034
Peking University People's Hospital
Beijing, 100044
Peking University Third Hospital
Beijing, 100191
People's Hospital of Sichuan Province
Chengdu, 610072
Second Affiliated Hospital Chongqing Medical University
Chongqing, 400016
The People's Hospital Of Xuancheng City
Xuancheng, 242000
Mexico6 sites
Centro de Investigacion Cardiometabolica de Aguascalientes
Aguascalientes, 20230
Centenario Hospital Miguel Hidalgo
Aguascalientes, 20259
Clinstile S.A. de C.V.
México, 06700
Instituto Nacional de Cs Médicas y Nutrición S Zubiran
Mexico City, 14000
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, 14080
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460
Canada5 sites
CARe Clinic
Red Deer, Alberta, T4P 1K4
Stouffville Medical Centre
Stouffville, Ontario, L4A 1H2
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Albion Finch Medical Centre
Toronto, Ontario, M9V 4B4
Fadia El Boreky Medicine Professional
Waterloo, Ontario, N2J 1C4
Malaysia5 sites
University Kebangsaan Malaysia
Cheras, Kuala Lumpur, 56000
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30450
Universiti Sains Malaysia Hospital
Kelantan, 16150
University of Malaya Medical Centre
Kuala Lumpur, 59100
Hospital Selayang
Kuala Selangor, 68100
Denmark4 sites
Aarhus University Hospital
Aarhus N, 8200
Herlev and Gentofte Hospital
Herlev, 2730
Holbæk Sygehus
Holbæk, 4300
Sjællands Universitetshospital
Roskilde, 4000
Hong Kong4 sites
Prince of Wales Hospital
Hong Kong, 999077
Princess Margaret Hospital
Hong Kong, 999077
Queen Mary Hospital
Hong Kong, 999077
Tung Wah Hospital
Hong Kong
Poland4 sites
Cardiovascular Centre of Malopolska
Chrzanów, 32-500
Pratia MCM Krakow
Krakow, 30-510
Cent.Clin.Hosp.Med.Univ.Lodz
Lodz, 92-213
Medicome Limited Liability Company
Oświęcim, 32600
Portugal4 sites
ULS da Região de Aveiro
Aveiro, 3810-164
CHLO, EPE - Hospital de Santa Cruz
Carnaxide, 2790-134
ULS de Santa Maria, E.P.E
Lisbon, 1649-035
Centro Hospitalar Universitário São João,EPE
Porto, 4200-319
New Zealand3 sites
Dunedin Hospital
Dunedin, 9054
P3 Research Kapiti
Paraparaumu, 5032
P3 Research
Tauranga, 3110
United Kingdom3 sites
Lakeside Surgery
Corby, NN17 2UR
University Hospital Coventry
Coventry, CV2 2DX
Barts and The London School of Medicine and Dentistry
London, EC1M 6BQ
Germany2 sites
Klinikum Region Hannover GmbH
Hanover, 30459
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
Russia2 sites
Moscow 1st State Med.Univ.n.a.I.M.Sechenov
Moscow, 119992
St. Petersburg GUZ City Hospital no. 31, St. Petersburg
Saint Petersburg, 197110
About this study
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 Non-diabetic Kidney Disease
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.
Read more
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Avenciguat, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvenciguatDrug
Also called BI 685509
Avenciguat
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Avenciguat 1 mg TID | Experimental | TID=ter in die (3 times a day) Receives: Drug: Avenciguat |
| Avenciguat 2 mg TID | Experimental | Not described Receives: Drug: Avenciguat |
| Avenciguat 3 mg TID | Experimental | Not described Receives: Drug: Avenciguat |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change from baseline in log transformed UACR measured in First Morning Void 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.
The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day. 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.
Measured: 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
Number of patients achieving urine albumin creatinine ratio (UACR) decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment.
During the 10-hour period every time the patient urinates, and the patient collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample.
Measured: 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
Number of patients achieving urine albumin creatinine ratio (UACR) decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment is reported. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day.
Measured: At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start27 Apr 2021
- Primary completion15 Aug 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736628
- Sponsor's protocol ID
- 1366-0022
- Other IDs
- 2020-002930-33
- Status last verified
- Aug 2024
- First submitted
- 1 Feb 2021
- Last updated
- 4 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38795055
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Non-diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT04736628
- Acronym / sponsor ID
- 1366-0022
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Posted 4 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Avenciguat 1 mg TID | Experimental | Drug: AvenciguatTID=ter in die (3 times a day) |
| Avenciguat 2 mg TID | Experimental | Drug: Avenciguat |
| Avenciguat 3 mg TID | Experimental | Drug: Avenciguat |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvenciguatAlso: BI 685509Avenciguat | Drug | Avenciguat 1 mg TID, Avenciguat 2 mg TID, Avenciguat 3 mg TID |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment
Time frame: 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.
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.
3 secondary outcomes
Change From Baseline in Log Transformed UACR Measured in First Morning Void Urine After 20 Weeks of Trial Treatment
Time frame: 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
Time frame: 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
Time frame: At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38795055Heerspink 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
RecruitingObservational study
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Gastric Antral Vascular Ectasia, Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
110 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avenciguat in people with Chronic Kidney Disease, run by Boehringer Ingelheim at 110 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in United States, Japan, Argentina, Australia, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04736628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.