AzTrials
AzTrials

Kidney Disease, ChronicPhase 2NCT05182840

A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease

A Phase 2 study testing BI 690517 and Empagliflozin in people with Kidney Disease, Chronic, run by Boehringer Ingelheim at 203 sites in 29 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 chronic kidney disease. People with and without type 2 diabetes can take part in this study. The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Disease, Chronic
What is being tested?
BI 690517 and Empagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
714 participants
Where
203 sitesin 29 countries
Study dates
11 Jan 2022to 10 Jul 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 of legal adult age (according to local legislation) and aged ≥ 18 years at time of consent.
  • estimated Glomerular Filtration Rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 30 and < 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis.
  • Urine Albumin Creatinine Ratio (UACR) ≥ 200 and < 5,000 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.1
  • If the patient is taking any of the following medications they should be on a stable dose for at least 4 weeks prior to visit 1 and until first randomisation prior to run-in with no planned change of the therapy during the trial: anti-hypertensives, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), endothelin receptor antagonists, low dose systemic steroids (e.g. prednisolone ≤10 mg or equivalent).
  • Treatment with a clinically appropriate, stable dose of either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both together), for ≥ 4 weeks prior to visit 1 and until first randomisation with no planned change of the therapy during the trial.
Show all 15Show fewer
  • In the Investigator's opinion, any kind of diagnosed chronic kidney disease (Diagnosis can be reached by standard clinical method, no biopsy required). Patients with diabetic kidney disease must have type 2 diabetes mellitus and their treatment (including GLP1 receptor agonist) should be unchanged or changes deemed minor (according to investigator's judgement) within 4 weeks prior to Visit 1 and until first randomisation.
  • Glycated Haemoglobin (HbA1c) < 10.0% at Visit 1 measured by the central laboratory.
  • Serum potassium ≤ 4.8 mmol/L at Visit 1 measured by the central laboratory.
  • Seated Systolic Blood Pressure (SBP) ≥ 110 and ≤ 160 mmHg and Diastolic Blood Pressure (DBP) ≥ 65 and ≤ 110 mmHg at Visit 1 (mean values from three Blood Pressure (BP) measurements) and optimised anti-hypertensive treatment according to local standard of care and investigator's judgement.
  • Body Mass Index (BMI) ≥ 18.5 and < 50 kg/m2 at Visit 1.
  • Women of child-bearing potential2 (WOCBP) must be ready and able to use highly effective methods of birth control. Such methods should be used throughout the trial. Men must be vasectomised or willing and able to use a condom if their partner is a WOCBP.
  • Additional inclusion criteria to be assessed before second randomisation (start of Treatment Period):
  • Serum potassium ≤ 4.8 mmol/L measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
  • eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 20 mL/min/1.73 m2 measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.

Who cannot join

  • Treatment with inhibitors of aldosterone mediated effects (e.g., mineralocorticoid receptor antagonists such as spironolactone), or intake of other potassium sparing diuretics (e.g., amiloride) within 7 days prior to first randomisation or planned during trial treatment phase.
  • Treatment with other Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)) within 4 weeks prior to Visit 1 and throughout screening or planned during the trial. 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.
  • Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus (e.g. Latent Autoimmune Diabetes (LADA))
  • Patients at increased risk of ketoacidosis in the opinion of the investigator.
  • Currently receiving Sodium-glucose cotransporter (SGLT)-2 or SGLT-1/2 inhibitor or planned initiation during the trial.
  • Further criteria apply.

Trial locations and contacts

203 sites in 29 countries.

203 sites in 29 countries

United States41 sites

  • New Mexico Clinical Research and Osteoporosis Center, Inc.

    Albuquerque, New Mexico, 87106

  • Triad Internal Medicine

    Asheboro, North Carolina, 27203

  • Heritage Valley Medical Group

    Beaver, Pennsylvania, 15009

  • Clinical Research of Brandon LLC

    Brandon, Florida, 33511

  • Diabetes & Endocrinology Associates of Stark County

    Canton, Ohio, 44718

  • Clearview Medical Research, LLC

    Canyon Country, California, 91351

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Horizon Research Group

    Coral Gables, Florida, 33134

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • Colorado Kidney Care

    Denver, Colorado, 80230

  • Academy Of Diabetes, Thyroid And Endocrine, PA

    El Paso, Texas, 79935

  • Aa Mrc Llc

    Flint, Michigan, 48504

  • Elite Research Center, LLC

    Flint, Michigan, 48532

  • Elixia Fort Lauderdale, LLC

    Fort Lauderdale, Florida, 33308

  • PrimeCare Medical Group

    Houston, Texas, 77024

  • Clinical Research Consultants, LLC

    Kansas City, Missouri, 64111

  • Knoxville Kidney Center PLLC

    Knoxville, Tennessee, 37923

  • Forte Family Practice

    Las Vegas, Nevada, 89103

  • South Florida Research Institute

    Lauderdale Lakes, Florida, 33313

  • Pacific Renal Associates

    Long Beach, California, 90806

  • P&I Clinical Research, LLC

    Lufkin, Texas, 75904

  • Aventiv Research Inc.

    Mesa, Arizona, 85206

  • San Marcus Research Clinic, Inc.

    Miami, Florida, 33014

  • Total Research Group, LLC

    Miami, Florida, 33126

  • Horizon Research Group, LLC

    Miami, Florida, 33150

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28557

  • Boise Kidney and Hypertension PLLC

    Nampa, Idaho, 83687

  • Amicis Research Center

    Northridge, California, 91324

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Pines Care Research Center

    Pembroke Pines, Florida, 33024

  • AKDHC Medical Research Services, LLC

    Phoenix, Arizona, 85027

  • Monument Health

    Rapid City, South Dakota, 57701

  • California Kidney Specialists

    San Dimas, California, 91773

  • Providence Medical Research Center

    Spokane, Washington, 99204

  • Simcare Medical Research, LLC

    Sugar Land, Texas, 77478

  • Universal Research Group, LLC

    Tacoma, Washington, 98405

  • Elixia Tampa, LLC

    Temple Terrace, Florida, 33637

  • Elixia Upland, LLC

    Upland, Pennsylvania, 19013

  • Kansas Nephrology Research Institute, LLC

    Wichita, Kansas, 67214

Other trials in United States

Japan14 sites

  • Daiyukai Clinic

    Aichi, Ichinomiya, 491-8551

  • Meitetsu Hospital

    Aichi, Nagoya, 451-8511

  • Nagoya Kyoritsu Hospital

    Aichi, Nagoya, 454-0933

  • TOSAKI Clinic for Diabetes and Endocrinology

    Aichi, Nagoya, 468-0009

  • National Hospital Organization Takasaki General Medical Center

    Gumma, Takasaki, 370-0829

  • Kyoto Okamoto Memorial Hospital

    Kyoto, Kuse-gun, 613-0034

  • Ina Central Hospital

    Nagano, Ina, 396-8555

  • Suwa Red Cross Hospital

    Nagano, Suwa, 392-8510

  • Asano Clinic

    Saitama, Kawagoe, 350-0851

  • Omihachiman Community Medical Center

    Shiga, Omihachiman, 523-0082

  • The University of Tokyo Hospital

    Tokyo, Bunkyo-ku, 113-8655

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, Hachioji, 193-0998

  • Miho Clinic

    Tokyo, Shinagawa-ku, 141-0032

  • Yamaura Medical Clinic

    Ueda, Nagano, 386-0407

Other trials in Japan

Poland14 sites

  • INTERCORE Medical Center

    Bydgoszcz, 85-605

  • Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk

    Gdansk, 80-382

  • Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice

    Katowice, 40-040

  • Pro Familia Altera

    Katowice, 40-648

  • Synexus Lodz Medical Center

    Lodz, 90127

  • Clinical Best Solutions

    Lublin, 20-078

  • NZOZ Specialized Ambulance "MEDICA"

    Lublin, 20-538

  • Hospitals of Tczew S.A.

    Pomorskie, 83-110

  • Omedica Medical Centre, Poznan

    Poznan, 60-111

  • Synexus Poland, Branch in Poznan

    Poznan, 60-702

  • Medical Center HCP Sp. z o.o

    Poznan, 61-485

  • Centrum Medyczne Synexus

    Warsaw, 02-672

  • Barwijuk Clinics

    Warsaw, 02-884

  • Synexus Poland, Branch in Wroclaw

    Wroclaw, 50-088

Other trials in Poland

India10 sites

  • Government Medical College & Hospital

    Chhatrapati Sambhajinagar, 431001

  • SMS Medical College and HospitaL

    Jaipur, 302001

  • Jaipur National University Institute for Medical Science & Research Centre

    Jaipur, 302017

  • Ganesh Shankar Vidyarthi Memorial Medical College

    Kanpur, 208002

  • K R Hospital Mysore Medical College and Research Centre

    Mysore, 570001

  • Kingsway Hospitals

    Nagpur, 440001

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Shree Giriraj Multispeciality Hospital

    Rajkot, 360005

  • Galaxy Lifecare Services Pvt. Ltd.

    Varanasi, 221010

  • Christian Medical College

    Vellore, 632004

Other trials in India

Brazil9 sites

  • Hospital Universitário João de Barros Barreto

    Belém, CEP 66073-

  • Faculdade de Medicina de Botucatu - UNESP

    Botucatu, 18618-687

  • Fundação Pró Renal Brasil

    Curitiba, 80440-020

  • Universidade Federal do Rio Grande do Sul

    Porto Alegre, 90430-001

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro, 22270-060

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, 09780-000

  • BR Trials

    São Paulo, 01236-030

  • Centro de Pesquisa Clinica - CPCLIN

    São Paulo, 01244-030

  • Hospital do RIM - UNIFESP

    São Paulo, 04023-062

Other trials in Brazil

Germany9 sites

  • Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen

    Bad Oeynhausen, 32545

  • Institut für klinische Forschung und Entwicklung (IKFE) Berlin GmbH

    Berlin, 10437

  • Cardiologicum Dresden und Pirna

    Dresden, 01277

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • DaVita Clinical Research Germany GmbH

    Düsseldorf, 40210

  • Synexus Clinical Research GmbH

    Frankfurt, 60313

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Synexus Clinical Research GmbH

    Leipzig, 04103

  • Universitätsklinikum Würzburg AÖR

    Würzburg, 97080

Other trials in Germany

Argentina8 sites

  • CIMEL centro de Investigaciones Médicas Lanús

    Buenos Aires, B1824KAJ

  • CEDIC - Centro de Investigacion Clinica

    CABA, C1060ABN

  • Glenny Corp. S.A. Bioclinica Argentina

    Ciudad Autonoma Buenos Aires, C1430CKE

  • Instituto Privado de Investigaciones Clínica Córdoba S.A.

    Córdoba, X5000AAW

  • Centro de Salud Renal Junín

    Junín, B6000GMA

  • Centro de Investigaciones Médicas Mar del Plata

    Mar del Plata, B7600FYK

  • Instituto Médico Catamarca - IMEC

    Rosario, S2000AJU

  • CEMEDIC - Centro de Especialidades Medicas

    Villa Luro, C1440CFD

Other trials in Argentina

South Africa8 sites

  • Iatros International

    Bloemfontein, 9324

  • Synexus Helderberg Clinical Research Centre

    Cape Town, 7130

  • TREAD Research

    Cape Town, 7500

  • Langeberg Clinical Trials

    Cape Town, 7570

  • Paarl Research Centre

    Cape Town, 7646

  • Latiff, GHVM

    Durban, 4001

  • DJW Navorsing

    Krugersdorp, 1739

  • Synexus Watermeyer Clinical Research Centre

    Pretoria, 0184

Other trials in South Africa

Hungary7 sites

  • Lausmed Kft. Outpatient Unit of Internal Medicine

    Baja, 6500

  • DRC Drug Research Ltd

    Balatonfüred, 8230

  • Synexus Hungary Healthcare Service Ltd.

    Budapest, 1036

  • Semmelweis University

    Budapest, 1083

  • University Debrecen Hospital

    Debrecen, 4032

  • Markhot Ferenc Hospital, Eger

    Eger, 3300

  • BKS Research Ltd

    Hatvan, 3000

Other trials in Hungary

Mexico7 sites

  • Centro de Investigacion Cardiometabolica de Aguascalientes

    Aguascalientes, 20230

  • Unidad de Investigación Clinica y Atencion Medica HEPA SC

    Guadalajara, 44670

  • Centro Mexicano de Desarrollo de Estudios Clínicos SA -CEMDEC

    México, 06100

  • Clinstile S.A. de C.V.

    México, 06700

  • CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc

    México, 11650

  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

    México, 20010

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Nuevo León, 64460

Other trials in Mexico

Philippines7 sites

  • Norzel Medical and Diagnostic Clinic

    Cebu City, 6000

  • Davao Doctors Hospital

    Davao City, 8000

  • West Visayas State University Medical Center

    Iloilo City, 5000

  • Institute for Studies on Diabetes Foundation Inc.

    Marikina City, 1810

  • The Medical City

    Pasig, 1605

  • Philippine Heart Center

    Quezon City, 850

  • Senor Santo Nino Hospital

    Tarlac City, 2306

Other trials in Philippines

Canada6 sites

  • LMC Clinical Research Inc. (Brampton)

    Brampton, Ontario, L6S 0C6

  • Recherche GCP Research

    Montreal, Quebec, H1M 1B1

  • The Bailey Clinic

    Red Deer, Alberta, T4N 6V7

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Sameh Fikry Medicine Professional Corporation

    Waterloo, Ontario, N2J 1C4

  • Shivinder Jolly, Nephrologist

    Waterloo, Ontario, N2T 0C1

Other trials in Canada

China6 sites

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • The First Afiliated Hospital, Sun Yet-sen University

    Guangzhou, 510080

  • Zhejiang Province People's Hospital

    Hangzhou, 310014

  • The First People's Hospital of Nanning

    Nanning, 530000

  • Huashan Hospital, Fudan University

    Shanghai, 200040

  • Shanghai Fifth People's Hospital affiliated to Fudan University

    Shanghai, 200240

Other trials in China

Malaysia6 sites

  • Hospital Selayang

    Batu Caves, 68100

  • University Kebangsaan Malaysia

    Cheras, Kuala Lumpur, 56000

  • Klinik Kesihatan Mahmoodiah

    Johor Bahru, 80100

  • Tuanku Fauziah Hospital

    Kangar, 01000

  • Hospital Raja Perempuan Zainab II, Kota Bharu

    Kota Bharu, 15200

  • Hospital Seri Manjung

    Seri Manjung, 32040

Other trials in Malaysia

Portugal6 sites

  • ULS de Almada -Seixal, E. P. E. - Hospital Garcia de Orta

    Almada, 2801-951

  • ULS da Região de Aveiro

    Aveiro, 3810-164

  • CHLO, EPE - Hospital de Santa Cruz

    Carnaxide, 2790-134

  • ULS da Região de Leiria, E.P.E.

    Leiria, 2410-197

  • APDP - Associação Protectora dos Diabéticos de Portugal

    Lisbon, 1250-189

  • ULS de Gaia/Espinho, EPE

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

South Korea6 sites

  • Korea University Ansan Hospital

    Ansan, 15355

  • Chungbuk National University Hospital

    Cheongiu, 28644

  • Inje University Ilsan Paik Hospital

    Goyang, 10380

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707

Other trials in South Korea

Belgium5 sites

  • Brussels - UNIV UZ Brussel

    Brussels, 1090

  • Brussels - UNIV Saint-Luc

    Brussels, 1200

  • La Louvière - UNIV CHU Tivoli

    La Louvière, 7100

  • UZ Leuven

    Leuven/Vlaams-Brabant, 3000

  • Charleroi - UNIV CHU de Charleroi

    Lodelinsart, 6042

Other trials in Belgium

Spain5 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Público Da Mariña

    Burela de Cabo, 27880

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Puerta de Hierro

    Majadahonda, 28222

Other trials in Spain

Bulgaria4 sites

  • Medical Center Rusemed

    Rousse, 7013

  • Robert Koch Clinic Sofia

    Sofia, 1407

  • Medical Center Synexus Sofia EOOD

    Sofia, 1784

  • MHAT Prof Stoyan Kirkovich AD

    Stara Zagora, 6000

Other trials in Bulgaria

Czechia4 sites

  • DIKa centrum s.r.o.

    Havířov, 73601

  • Synexus Czech s.r.o.

    Prague, 120 00

  • MILAN KVAPIL s.r.o.

    Příbram, 26101

  • Hospital Slany, Internal Department

    Slaný, 274 01

Other trials in Czechia

Greece4 sites

  • General Hospital of Athens "Laiko"

    Athens, 115 27

  • "Attiko" Hospital of Athens

    Athens, 124 62

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 455 00

  • Iatriko of Athens Group/ Iatriko of P. Faliro

    P. Faliro, 17562

Other trials in Greece

Australia3 sites

  • Monash University

    Box Hill, Victoria, 3128

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

Other trials in Australia

Finland3 sites

  • Satucon Oy

    Kuopio, 70100

  • Tampere University Hospital

    Tampere, 33521

  • Turku University Hospital / TYKS

    Turku, 20520

Other trials in Finland

Sweden3 sites

  • Centralsjukhuset, Kristianstad

    Kristianstad, 291 33

  • Universitetssjukhuset, Linköping

    Linköping, 581 85

  • Citydiabetes, Stockholm

    Stockholm, 112 21

Other trials in Sweden

Hong Kong2 sites

  • Prince of Wales Hospital

    Hong Kong, 999077

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Italy2 sites

  • A.O. Policlinico Giovanni XXIII di Bari

    Bari, 70124

  • ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII

    Bergamo, 24127

Other trials in Italy

Norway2 sites

  • Akershus Universitetssykehus HF

    Nordbyhagen, 1478

  • Helse Stavanger, Stavanger Universitetssykehus

    Stavanger, 4011

Other trials in Norway

Switzerland1 site

  • University Hospital of Lausanne

    Lausanne, 1011

Other trials in Switzerland

Turkey (Türkiye)1 site

  • Istanbul University

    Istanbul, 34093

Other trials in Turkey (Türkiye)

About this study

Official title: Randomised, Double-blind, Placebo-controlled and Parallel Dose Group Trial to Investigate Efficacy and Safety of Multiple Doses of Oral BI 690517 Over 14 Weeks, Alone and in Combination With Empagliflozin, in Patients With Diabetic and Non-diabetic Chronic Kidney Disease

This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study.

The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin.

Read more

In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine.

In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine.

Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 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.

Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Being tested
BI 690517, Placebo to BI 690517, Empagliflozin, Placebo to empagliflozin
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.

  • BI 690517Drug

    Also called Vicadrostat

    Film-coated tablets

  • Placebo to BI 690517Drug

    Film-coated tablets

  • EmpagliflozinDrug

    Empagliflozin

  • Placebo to empagliflozinDrug

    Placebo to empagliflozin

Study groups in NCT05182840
Study groupRoleWhat they receive
Run-in period: 10 mg empagliflozinExperimentalNot described
Receives: Drug: Empagliflozin
Run-in period: Placebo to empagliflozin 10 mgPlacebo comparatorNot described
Receives: Drug: Placebo to empagliflozin
Treatment period: 10 mg empagliflozin + 3 mg BI 690517ExperimentalNot described
Receives: Drug: BI 690517; Drug: Empagliflozin
Treatment period: 10 mg empagliflozin + 10 mg BI 690517ExperimentalNot described
Receives: Drug: BI 690517; Drug: Empagliflozin
Treatment period: 10 mg empagliflozin + 20 mg BI 690517ExperimentalNot described
Receives: Drug: BI 690517; Drug: Empagliflozin
Treatment period: 10 mg empagliflozin + Placebo to BI 690517Placebo comparatorNot described
Receives: Drug: Placebo to BI 690517; Drug: Empagliflozin
Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517ExperimentalNot described
Receives: Drug: BI 690517; Drug: Placebo to empagliflozin
Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517ExperimentalNot described
Receives: Drug: BI 690517; Drug: Placebo to empagliflozin
Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517ExperimentalNot described
Receives: Drug: BI 690517; Drug: Placebo to empagliflozin
Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517Placebo comparatorNot described
Receives: Drug: Placebo to BI 690517; Drug: Placebo to empagliflozin

What is being measured

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

  1. Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients

    The adjusted mean change (95% confidence interval) in log transformed FMV UACR from baseline at 14 weeks is presented.

    The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

    Measured: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

  2. Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients

    Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for all patients is presented.

    Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)*100/(FMV UACR at baseline).

    MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

    Measured: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

  3. Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin

    The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented.

    The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

    Measured: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

  4. Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - Patients With Background Therapy of Placebo Matching Empagliflozin

    Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented.

    Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)*100/(FMV UACR at baseline).

    MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

    Measured: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

  5. Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin

    The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of empagliflozin in the Run-in period is presented.

    The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

    Measured: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

  6. Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of Empagliflozin

    Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of empagliflozin in the Run-in period is presented.

    Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)*100/(FMV UACR at baseline).

    MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

    Measured: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

Secondary outcomes (24)

  1. UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Multiple Imputation

    Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

    Measured: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

  2. UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder

    Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    The missing as non-responder imputes patients with missing Week 14 data as non-responders.

    Measured: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

  3. UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF)

    Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

    Measured: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

  4. UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis

    Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    Complete case analysis used patients with both baseline and Week 14 data available.

    Measured: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

  5. UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation

    Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

    Measured: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

  6. UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder

    Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    The missing as non-responder imputes patients with missing Week 14 data as non-responders.

    Measured: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

  7. UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)

    Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks.

    LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

    Measured: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

  8. UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis

    Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    Complete case analysis used patients with both baseline and Week 14 data available.

    Measured: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

  9. UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation

    Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

    Measured: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

  10. UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder

    Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    The missing as non-responder imputes patients with missing Week 14 data as non-responders.

    Measured: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

  11. UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward

    Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14.

    Measured: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

  12. UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis

    Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    Complete case analysis used patients with both baseline and Week 14 data available.

    Measured: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

  13. UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients -Multiple Imputation

    Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 week. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

    Measured: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

  14. UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder

    Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    The missing as non-responder imputes patients with missing Week 14 data as non-responders.

    Measured: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

  15. UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Last Observation on Treatment Carried Forward (LOCF)

    Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

    Measured: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

  16. UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis

    Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    Complete case analysis used patients with both baseline and Week 14 data available.

    Measured: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

  17. UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation

    Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

    Measured: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

  18. UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder

    Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    The missing as non-responder imputes patients with missing Week 14 data as non-responders.

    Measured: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

  19. UACR Response II, Defined as Decrease of at Least 15% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)

    Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks.

    LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

    Measured: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

  20. UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation

    Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

    Measured: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

  21. UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder

    Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    The missing as non-responder imputes patients with missing Week 14 data as non-responders.

    Measured: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

  22. UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward

    Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14.

    Measured: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

  23. UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks -Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis

    Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    Complete case analysis used patients with both baseline and Week 14 data available.

    Measured: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

  24. UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis

    Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

    Complete case analysis used patients with both baseline and Week 14 data available.

    Measured: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Timeline

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

  1. First posted10 Jan 2022
  2. Study start11 Jan 2022
  3. Primary completion19 Jun 2023
  4. Study completion10 Jul 2023

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
714 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05182840
Sponsor's protocol ID
1378.5
Other IDs
2021-001434-19, 1378-0005
Status last verified
Oct 2024
First submitted
5 Jan 2022
Last updated
22 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the time frame criteria given under number 4 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

  • Cherney DZI, Rossing P, Canziani ME, Caramori ML, Correa-Rotter R, Cronin L, Hugo C, Ji B, Meyerhoff J, Nangaku M, Silva A, Urbach D, Shah SV, de Zeeuw D, Tuttle KR. Effects of Vicadrostat/Empagliflozin in People With Chronic Kidney Disease: Metabolic Subgroup Analyses. Diabetes Obes Metab. 2026 Jul;28(7):6324-6333. doi: 10.1111/dom.70836. Epub 2026 May 5.

    PubMed 42086479

  • Gashaw IA, Tuttle KR, Monroy Kuhn M, Pleiner S, Delic D, Cronin L, Shah SV, Rossing P. Pharmacodynamics of vicadrostat for aldosterone synthase inhibition in patients with CKD. Eur J Endocrinol. 2026 Jan 6;194(1):46-57. doi: 10.1093/ejendo/lvaf265.

    PubMed 41436034

  • Tuttle KR, Hauske SJ, Canziani ME, Caramori ML, Cherney D, Cronin L, Heerspink HJL, Hugo C, Nangaku M, Rotter RC, Silva A, Shah SV, Sun Z, Urbach D, de Zeeuw D, Rossing P; ASi in CKD group. Efficacy and safety of aldosterone synthase inhibition with and without empagliflozin for chronic kidney disease: a randomised, controlled, phase 2 trial. Lancet. 2024 Jan 27;403(10424):379-390. doi: 10.1016/S0140-6736(23)02408-X. Epub 2023 Dec 15.

    PubMed 38109916

  • Tuttle KR, Rossing P, Hauske SJ, Cronin L, Hussain J, de Zeeuw D, Heerspink HJL. Methods Article for a Study Protocol: Study Design and Baseline Characteristics for Aldosterone Synthase Inhibition in Chronic Kidney Disease. Am J Nephrol. 2024;55(2):262-272. doi: 10.1159/000534808. Epub 2023 Oct 30.

    PubMed 37903483

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 690517 and Empagliflozin in people with Kidney Disease, Chronic, run by Boehringer Ingelheim at 203 sites in 29 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 15 inclusion and 6 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 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 203 sites in United States, Japan, Poland, India, Brazil and 24 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 29 Aug 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 Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients (time frame: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.). The study lists 6 primary outcomes in all. 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 NCT05182840, which also lists 4 linked publications.

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 22 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in