BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease
NCT ID: NCT01345656
Last Updated: 2022-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
457 participants
INTERVENTIONAL
2011-05-09
2012-07-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
BAY94-8862
Two 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks
Arm 2
BAY94-8862
Four 1.25 mg BAY94-8862 tablets for duration of 4 weeks
Arm 3
BAY94-8862
One 10 mg BAY94-8862 tablet for duration of 4 weeks
Arm 4
BAY94-8862
Part B only: Four 1.25 mg BAY94-8862 tablets in the morning and four tablets in the evening for duration of 4 weeks
Arm 5
Placebo
Placebo tablets for duration of 4 weeks
Arm 6
Spironolactone
Part B only: 25 mg spironolactone once daily with up-titration to 50 mg once daily starting at day 15, if serum potassium is less or equal to 4.8 mmol/L, for duration of 4 weeks
Interventions
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BAY94-8862
Two 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks
BAY94-8862
Four 1.25 mg BAY94-8862 tablets for duration of 4 weeks
BAY94-8862
One 10 mg BAY94-8862 tablet for duration of 4 weeks
BAY94-8862
Part B only: Four 1.25 mg BAY94-8862 tablets in the morning and four tablets in the evening for duration of 4 weeks
Placebo
Placebo tablets for duration of 4 weeks
Spironolactone
Part B only: 25 mg spironolactone once daily with up-titration to 50 mg once daily starting at day 15, if serum potassium is less or equal to 4.8 mmol/L, for duration of 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of CHF (chronic heart failure), either ischemic or non-ischemic, NYHA (New York Heart Association) class II - III, treated with evidenced-based therapy for CHF, e.g. beta-blockers and ACE (angiotensin-converting enzyme) inhibitors or ARB (angiotensin receptor blocker) as well as diuretics, unless contraindicated or not tolerated
* Known kidney damage for \>/= 3 months, as defined by structural or functional abnormalities of the kidney, and
* Part A: 60 mL/min/1.73 m\*2 \</= eGFR (estimated Glomerular Filtration Rate) \< 90 mL/min/1.73 m\*2 (MDRD, Modification of Diet in Renal Disease) at the screening visit
* Part B: 30 mL/min/1.73 m\*2 \</= eGFR \<= 60 mL/min/1.73 m\*2 (MDRD) at the screening visit
* Serum potassium \</= 4.8 mmol/L at the screening visit
* Systolic blood pressure \>/= 90 mmHg without signs or symptoms of hypotension at the screening visit
Exclusion Criteria
* Subjects with anuria, acute renal failure, or Addison's disease
* Acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization
* Valvular heart disease requiring surgical intervention during the course of the study
* History of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Graz, Styria, Austria
Linz, Upper Austria, Austria
Vienna, , Austria
Brasschaat, , Belgium
Bruxelles - Brussel, , Belgium
Roeselare, , Belgium
Brno, , Czechia
Liberec, , Czechia
Prague, , Czechia
Prague, , Czechia
Copenhagen Ø, , Denmark
Esbjerg, , Denmark
Frederiksberg, , Denmark
Hellerup, , Denmark
Herlev, , Denmark
Hvidovre, , Denmark
København NV, , Denmark
Køge, , Denmark
Odense, , Denmark
Svendborg, , Denmark
Viborg, , Denmark
Helsinki, , Finland
Jyväskylä, , Finland
Turku, , Finland
Frankfurt am Main, Hesse, Germany
Cologne, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Wermsdorf, Saxony, Germany
Wedel, Schleswig-Holstein, Germany
Erfurt, Thuringia, Germany
Berlin, , Germany
Afula, , Israel
Ashkelon, , Israel
Hadera, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Safed, , Israel
Tel Aviv, , Israel
Oslo, , Norway
Stavanger, , Norway
Krakow, , Poland
Piotrkow Trybunalski, , Poland
Szczecin, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Kristianstad, , Sweden
Lund, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Countries
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References
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Pitt B, Filippatos G, Gheorghiade M, Kober L, Krum H, Ponikowski P, Nowack C, Kolkhof P, Kim SY, Zannad F. Rationale and design of ARTS: a randomized, double-blind study of BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic kidney disease. Eur J Heart Fail. 2012 Jun;14(6):668-75. doi: 10.1093/eurjhf/hfs061. Epub 2012 May 4.
Pitt B, Kober L, Ponikowski P, Gheorghiade M, Filippatos G, Krum H, Nowack C, Kolkhof P, Kim SY, Zannad F. Safety and tolerability of the novel non-steroidal mineralocorticoid receptor antagonist BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic kidney disease: a randomized, double-blind trial. Eur Heart J. 2013 Aug;34(31):2453-63. doi: 10.1093/eurheartj/eht187. Epub 2013 May 27.
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.
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.
Related Links
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Click here to find information about studies related to Bayer products conducted in Europe
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Other Identifiers
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2011-000301-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14563
Identifier Type: -
Identifier Source: org_study_id
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