Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

NCT ID: NCT01807221

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1066 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-17
• Study Completion Date: 2014-12-09

Brief Summary

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Finerenone(BAY94-8862)[2.5mg] + Placebo

Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.

Group Type: EXPERIMENTAL

Finerenone (BAY94-8862)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Finerenone (BAY94-8862)[5mg] + Placebo

Oral - 5mg OD for 30 days. Potential up-titration to 10 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.

Group Type: EXPERIMENTAL

Finerenone (BAY94-8862)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Finerenone (BAY94-8862)[7.5mg] + Placebo

Oral - 7.5mg OD for 30 days. Potential up-titration to 15 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.

Group Type: EXPERIMENTAL

Finerenone (BAY94-8862)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Finerenone (BAY94-8862)[10mg] + Placebo

Oral - 10mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.

Group Type: EXPERIMENTAL

Finerenone (BAY94-8862)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Finerenone (BAY94-8862)[15mg] + Placebo

Oral - 15mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.

Group Type: EXPERIMENTAL

Finerenone (BAY94-8862)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eplerenone [25 mg] + Placebo

Oral - 25mg every other day (EOD). Potential up-titration to 25mg OD after 30 days and 50mg OD after 60 days.Placebo OD for 90 days.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Inspra (eplerenone)

Intervention Type: DRUG

Interventions

Finerenone (BAY94-8862)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Inspra (eplerenone)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men and women aged 18 years and older. The lower age limit may be higher if legally required in the participating country
• Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active
• Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital
• Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non ischemic, New York Heart Association (NYHA) functional class II-IV
• Subjects with type 2 diabetes mellitus and / or
• Subjects with 30 mL/min/1.73m^2 </= eGFR </= 60 mL/min/1.73m^2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening
• Left ventricular ejection fraction (LVEF) </= 40%
• Blood potassium </= 5.0 mmol/L at screening
• Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the screening visit

Exclusion Criteria

• Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
• Acute coronary syndrome (ACS) in last 30 days prior to screening
• Cardiogenic shock
• Valvular heart disease requiring surgical intervention during the course of the study
• Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
• Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin inhibitor, or potassium-sparing diuretic

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Birmingham, Alabama, United States

La Jolla, California, United States

Los Angeles, California, United States

Jacksonville, Florida, United States

Macon, Georgia, United States

Baltimore, Maryland, United States

Detroit, Michigan, United States

Detroit, Michigan, United States

Newark, New Jersey, United States

Fairfield, Ohio, United States

Darlinghurst, New South Wales, Australia

Adelaide, South Australia, Australia

Concord, , Australia

Prahran, , Australia

Krems, Lower Austria, Austria

Graz, Styria, Austria

Graz, Styria, Austria

Innsbruck, Tyrol, Austria

Linz, Upper Austria, Austria

Salzburg, , Austria

Vienna, , Austria

Burgas, , Bulgaria

Pazardzhik, , Bulgaria

Rousse, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Varna, , Bulgaria

Calgary, Alberta, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Saint-Jean-sur-Richelieu, Quebec, Canada

Sherbrooke, Quebec, Canada

Québec, , Canada

Jindřichův Hradec, , Czechia

Ostrava, , Czechia

Prague, , Czechia

Slaný, , Czechia

Copenhagen Ø, , Denmark

Esbjerg, , Denmark

Glostrup Municipality, , Denmark

Hellerup, , Denmark

Herlev, , Denmark

Hvidovre, , Denmark

København NV, , Denmark

Køge, , Denmark

Svendborg, , Denmark

Viborg, , Denmark

Espoo, , Finland

Helsinki, , Finland

Rovaniemi, , Finland

Turku, , Finland

Bron, , France

Nice, , France

Paris, , France

Paris, , France

Rouen, , France

Toulouse, , France

Vandœuvre-lès-Nancy, , France

Würzburg, Bavaria, Germany

Frankfurt am Main, Hesse, Germany

Limburg an der Lahn, Hesse, Germany

Göttingen, Lower Saxony, Germany

Hanover, Lower Saxony, Germany

Stade, Lower Saxony, Germany

Bad Oeynhausen, North Rhine-Westphalia, Germany

Mönchengladbach, North Rhine-Westphalia, Germany

Homburg, Saarland, Germany

Erfurt, Thuringia, Germany

Berlin, , Germany

Athens, , Greece

Athens, , Greece

Chaïdári, , Greece

Larissa, , Greece

Nea Ionia / Athens, , Greece

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Nagykanizsa, , Hungary

Székesfehérvár, , Hungary

Afula, , Israel

Ashkelon, , Israel

Hadera, , Israel

Haifa, , Israel

Jerusalem, , Israel

Kfar Saba, , Israel

Nahariya, , Israel

Petah Tikva, , Israel

Rehovot, , Israel

Safed, , Israel

Tel Aviv, , Israel

Ẕerifin, , Israel

Foggia, Apulia, Italy

Rome, Lazio, Italy

Bergamo, Lombardy, Italy

Milan, Lombardy, Italy

Monza Brianza, Lombardy, Italy

Arezzo, Tuscany, Italy

Pisa, Tuscany, Italy

Perugia, Umbria, Italy

Kaunas, , Lithuania

Kaunas, , Lithuania

Kaunas, , Lithuania

Klaipėda, , Lithuania

Klaipėda, , Lithuania

Vilnius, , Lithuania

Amsterdam, , Netherlands

Delft, , Netherlands

Groningen, , Netherlands

Groningen, , Netherlands

Hoogeveen, , Netherlands

Nijmegen, , Netherlands

Rotterdam, , Netherlands

Veldhoven, , Netherlands

Zutphen, , Netherlands

Stavanger, , Norway

Bialystok, , Poland

Bydgoszcz, , Poland

Gdansk, , Poland

Katowice, , Poland

Kielce, , Poland

Krakow, , Poland

Szczecin, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Almada, , Portugal

Faro, , Portugal

Lisbon, , Portugal

Lisbon, , Portugal

Lisbon, , Portugal

Porto, , Portugal

Petoria, Gauteng, South Africa

Isipingo Rail, KwaZulu-Natal, South Africa

Merebank, KwaZulu-Natal, South Africa

Tongaat, KwaZulu-Natal, South Africa

Cape Town, Western Cape, South Africa

Kuils River, Western Cape, South Africa

Pinelands, Western Cape, South Africa

Somerset West, Western Cape, South Africa

Worcester, Western Cape, South Africa

Wŏnju, Gang''weondo, South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Olot, Girona, Spain

Majadahonda, Madrid, Spain

El Palmar, Murcia, Spain

Barcelona, , Spain

Barcelona, , Spain

Madrid, , Spain

Valencia, , Spain

Valencia, , Spain

Falun, , Sweden

Gothenburg, , Sweden

Örebro, , Sweden

Stockholm, , Sweden

Stockholm, , Sweden

Stockholm, , Sweden

Umeå, , Sweden

New Taipei City, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taizung, , Taiwan

Ankara, , Turkey (Türkiye)

Ankara, , Turkey (Türkiye)

Ankara, , Turkey (Türkiye)

Antalya, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Countries

United States; Australia; Austria; Bulgaria; Canada; Czechia; Denmark; Finland; France; Germany; Greece; Hungary; Israel; Italy; Lithuania; Netherlands; Norway; Poland; Portugal; South Africa; South Korea; Spain; Sweden; Taiwan; Turkey (Türkiye)

References

Filippatos G, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Kim SY, Nowack C, Palombo G, Kolkhof P, Kimmeskamp-Kirschbaum N, Pieper A, Pitt B. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29.

Reference Type: RESULT

PMID: 27130705 (View on PubMed)

Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

Reference Type: RESULT

PMID: 33107592 (View on PubMed)

Pitt B, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Nowack C, Kim SY, Pieper A, Kimmeskamp-Kirschbaum N, Filippatos G. Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF): a randomized study of finerenone vs. eplerenone in patients who have worsening chronic heart failure with diabetes and/or chronic kidney disease. Eur J Heart Fail. 2015 Feb;17(2):224-32. doi: 10.1002/ejhf.218.

Reference Type: RESULT

PMID: 25678098 (View on PubMed)

Ostrominski JW, Filippatos G, Claggett BL, Miao ZM, Desai AS, Jhund PS, Henderson A, Rohwedder K, Brinker MD, Scalise A, Schloemer P, Lam CSP, Senni M, Shah SJ, Voors AA, Zannad F, Rossing P, Ruilope LM, Anker SD, Pitt B, Agarwal R, McMurray JJV, Solomon SD, Vaduganathan M. Effect of Finerenone on Morbidity and Mortality in CKD. J Am Soc Nephrol. 2025 Sep 12. doi: 10.1681/ASN.0000000823. Online ahead of print. No abstract available.

Reference Type: DERIVED

PMID: 40938666 (View on PubMed)

Related Links

http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer Healthcare products.

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

2012-002627-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14564

Identifier Type: -

Identifier Source: org_study_id