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Diabetic NephropathiesPhase 2NCT04750577

A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease

A Phase 2 study testing BI 685509 in people with Diabetic Nephropathies, run by Boehringer Ingelheim at 78 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Nephropathies
What is being tested?
BI 685509
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
243 participants
Where
78 sitesin 16 countries
Study dates
27 Apr 2021to 27 Dec 2022
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 of 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.
  • 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.
  • 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.
  • 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.
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  • 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.
  • Glycated Haemoglobin (HbA1c) < 10.0% at Visit 1 measured by the central laboratory.
  • 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), 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.
  • Any clinically relevant laboratory value from screening until start of trial treatment, which in the investigator's judgement puts the patient at additional risk.
  • 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).
  • 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).
  • 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.
  • Planned start of chronic renal replacement therapy during the trial or end stage renal disease before start of trial treatment.
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  • 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

78 sites in 16 countries.

78 sites in 16 countries

United States17 sites

  • Research by Design, LLC

    Chicago, Illinois, 60643

  • Davita Clinical Research

    Columbus, Georgia, 31904

  • Indago Research and Health Center

    Hialeah, Florida, 33012

  • DaVita Clinical Research

    Houston, Texas, 77054

  • Knoxville Kidney Center PLLC

    Knoxville, Tennessee, 37923

  • DaVita Clinical Research

    Las Vegas, Nevada, 89128

  • Texas Institute for Kidney and Endocrine Disorders

    Lufkin, Texas, 75904

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Tidewater Kidney Specialists

    Norfolk, Virginia, 23510

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

  • DaVita Clinical Research

    San Antonio, Texas, 78240

  • Meridian Clinical Research, LLC

    Savannah, Georgia, 31406

  • Kidney Specialists of North Houston, PLLC

    Shenandoah, Texas, 77384

  • Total Renal Research

    The Bronx, New York, 10461

  • Kidney & Hypertension Center

    Victorville, California, 92395

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Brookview Hills Research Associates LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan12 sites

  • Chubu Rosai Hospital

    Aichi, Nagoya, 455-8530

  • Daido Hospital

    Aichi, Nagoya, 457-8511

  • Kurume University Hospital

    Fukuoka, Kurume, 830-0011

  • Nakayamadera Imai Clinic

    Hyogo, Takarazuka, 665-0861

  • Takai Naika Clinic

    Kanagawa, Kamakura, 247-0056

  • Kawasaki Medical School Hospital

    Okayama, Kurashiki, 701-0192

  • Osaka General Medical Center

    Osaka, Osaka, 558-8558

  • OCROM Clinic

    Osaka, Suita, 565-0853

  • Saitama Medical University Hospital

    Saitama, Iruma-gun, 350-0495

  • The University of Tokyo Hospital

    Tokyo, Bunkyo-ku, 113-8655

  • Tokyo-Eki Center-building Clinic

    Tokyo, Chuo-ku, 103-0027

  • ToCROM Clinic

    Tokyo, Shinjyuku-ku, 160-0008

Other trials in Japan

Argentina6 sites

  • CEDIC - Centro de Investigacion Clinica

    CABA, C1060ABN

  • Instituto Médico Especializado

    Capital Federal, C1405BCH

  • Instituto Privado de Investigaciones Clínica Córdoba S.A.

    Córdoba, X5000AAW

  • Centro de Investigaciones Médicas Mar del Plata

    Mar del Plata, B7600FYK

  • Instituto Médico Catamarca - IMEC

    Rosario, S2000AJU

  • CEREHA S.A.- Centro de Estudios Renales e Hipertensión Arterial

    Sarandí, B1872EEB

Other trials in Argentina

Australia6 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 North Shore Hospital

    St Leonards, New South Wales, 2065

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

China4 sites

  • Peking University First Hospital

    Beijing, 100034

  • Peking University Third Hospital

    Beijing, 100191

  • Second Affiliated Hospital Chongqing Medical University

    Chongqing, 400016

  • People's Hospital of Sichuan Province

    Sichuan, 610031

Other trials in China

Malaysia4 sites

  • University Kebangsaan Malaysia

    Cheras, Kuala Lumpur, 56000

  • Universiti Sains Malaysia Hospital

    Kelantan, 16150

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Selayang

    Kuala Selangor, 68100

Other trials in Malaysia

Mexico4 sites

  • Hospital Cardiologica Aguascalientes

    Aguascalientes, 20230

  • Centenario Hospital Miguel Hidalgo

    Aguascalientes, 20259

  • Clinstile S.A. de C.V.

    México, 06700

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

Other trials in Mexico

Poland4 sites

  • SPECDERM Poznanska General Partnership

    Bialystok, 15-375

  • Pratia MCM Krakow

    Krakow, 30-510

  • Medicome Limited Liability Company

    Oświęcim, 32-600

  • NBR Polska

    Warsaw, 00710

Other trials in Poland

Spain4 sites

  • Hospital A Coruña

    A Coruña, 15006

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Virgen Macarena

    Seville, 41009

  • Hospital Clínico de Valencia

    Valencia, 46010

Other trials in Spain

Canada3 sites

  • CARe Clinic

    Red Deer, Alberta, T4P 1K4

  • Albion Finch Medical Centre

    Toronto, Ontario, M9V 4B4

  • Fadia El Boreky Medicine Professional

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Denmark3 sites

  • Aarhus University Hospital

    Aarhus N, 8200

  • Steno Diabetes Center Copenhagen

    Herlev, 2730

  • Sjællands Universitetshospital

    Roskilde, 4000

Other trials in Denmark

Hong Kong3 sites

  • Prince of Wales Hospital

    Hong Kong, 999077

  • Queen Mary Hospital

    Hong Kong, 999077

  • Tung Wah Hospital

    Hong Kong

Other trials in Hong Kong

Netherlands2 sites

  • Albert SchweitzerZiekenhuis

    Dordrecht, 3318 AT

  • Universitair Medisch Centrum Utrecht

    GA Utrecht, 3508

Other trials in Netherlands

New Zealand2 sites

  • P3 Research Kapiti

    Paraparaumu, 5032

  • P3 Research

    Tauranga, 3110

Other trials in New Zealand

Portugal2 sites

  • ULS da Região de Aveiro

    Aveiro, 3810-164

  • APDP - Associação Protectora dos Diabéticos de Portugal

    Lisbon, 1250-189

Other trials in Portugal

United Kingdom2 sites

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Barts and The London School of Medicine and Dentistry

    London, EC1M 6BQ

Other trials in United Kingdom

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 Diabetic Kidney Disease

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.

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 BI 685509 and placebo. During the study, the doctors also regularly check the general health of the participants.

Being tested
Placebo matching BI 685509, BI 685509
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo matching BI 685509Drug

    film-coated tablet

  • BI 685509Drug

    Also called Avenciguat

    film-coated tablet

Study groups in NCT04750577
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo matching BI 685509
BI 685509 1 mg TIDExperimentalNot described
Receives: Drug: BI 685509
BI 685509 2 mg TIDExperimentalLow dose followed by up-titration to medium dose.
Receives: Drug: BI 685509
BI 685509 3 mg TIDExperimentalLow dose followed by up-titration to medium dose, followed by up-titration to high-dose.
Receives: Drug: BI 685509

What is being measured

The primary outcome is the main question the study is designed to answer.

  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) after 20 weeks is reported. As soon as the First Morning Void sample was collected the clock starts for the 10-hour urine collection. During the 10-hour period every time the patient urinates, they collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample. Least Square Means and Standard error were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based 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 Least Squares Mean (Standard error) at Week 20 is reported.

    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.

Secondary outcomes (3)

  1. Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void Urine After 20 Weeks of Trial Treatment

    Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine 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. Least Square Means and Standard error were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based 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 Least Squares Mean (Standard error) at Week 20 is reported.

    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.

  2. 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 is reported. As soon as the First Morning Void sample was collected the clock starts for the 10-hour urine collection. During the 10-hour period every time the patient urinates, they collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample.

    Measured: Baseline (day -14 and -7) and week 20 (day 141).

  3. 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 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: Baseline (day -14 and -7) and week 20 (day 141).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2021
  2. Study start27 Apr 2021
  3. Primary completion30 Nov 2022
  4. Study completion27 Dec 2022

Resources

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
Model description
Multicentre, randomised, double-blind (within dose groups), parallel, placebo-controlled trial. Patients will be randomised equally into one of three parallel dose groups, and in each dose group to treatment either with BI 685509 or matching placebo in a 3:1 ratio.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04750577
Sponsor's protocol ID
1366-0005
Other IDs
2020-002929-28
Status last verified
Jul 2024
First submitted
9 Feb 2021
Last updated
23 Jul 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 685509 in people with Diabetic Nephropathies, run by Boehringer Ingelheim at 78 sites in 16 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 9 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Japan, Argentina, Australia, China and 11 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 23 Jul 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 and Week -1) 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 NCT04750577, 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 23 Jul 2024.

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Clinical Trial NCT04750577 | AzTrials