BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease
ARTS
A Randomized, Double-blind, Multi-center Study to Assess Safety and Tolerability of Different Oral Doses of BAY94-8862 in Subjects With Stable Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease Versus Placebo (Part A) or Versus Placebo and Spironolactone (Part B)
2 other identifiers
interventional
457
10 countries
50
Brief Summary
A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 heart-failure
Started May 2011
Shorter than P25 for phase_2 heart-failure
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2011
CompletedFirst Posted
Study publicly available on registry
May 2, 2011
CompletedStudy Start
First participant enrolled
May 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2012
CompletedFebruary 10, 2022
January 1, 2022
1.1 years
April 29, 2011
January 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of serum potassium
4 weeks
Secondary Outcomes (3)
Change in serum magnesium
Day 8, Day 15, Day 22, Day 29
Change in blood pressure
Day 8, Day 15, Day 22, Day 29
Change in heart rate
Day 8, Day 15, Day 22, Day 29
Study Arms (6)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
EXPERIMENTALArm 4
EXPERIMENTALArm 5
PLACEBO COMPARATORArm 6
ACTIVE COMPARATORInterventions
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
You may qualify if:
- Men aged 18 years and older or postmenopausal women aged 55 years and older or women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy
- 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
You may not qualify if:
- Known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (Part B only)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (50)
Unknown Facility
Graz, Styria, 8036, Austria
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Linz, Upper Austria, 4010, Austria
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Vienna, 1100, Austria
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Brasschaat, 2930, Belgium
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Bruxelles - Brussel, 1200, Belgium
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Roeselare, 8800, Belgium
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Brno, 625 00, Czechia
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Liberec, 460 63, Czechia
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Prague, 12808, Czechia
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Prague, 15030, Czechia
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Copenhagen Ø, 2100, Denmark
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Esbjerg, 6700, Denmark
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Frederiksberg, 2000, Denmark
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Hellerup, 2900, Denmark
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Herlev, 2730, Denmark
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Hvidovre, 2650, Denmark
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København NV, 2400, Denmark
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Køge, 4600, Denmark
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Odense, 5000, Denmark
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Svendborg, 5700, Denmark
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Viborg, 8800, Denmark
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Helsinki, FIN-00260, Finland
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Jyväskylä, FI-40620, Finland
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Turku, FIN-20520, Finland
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Frankfurt am Main, Hesse, 60596, Germany
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Cologne, North Rhine-Westphalia, 50968, Germany
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Dresden, Saxony, 01277, Germany
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Wermsdorf, Saxony, 04779, Germany
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Wedel, Schleswig-Holstein, 22880, Germany
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Erfurt, Thuringia, 99084, Germany
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Berlin, 13353, Germany
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Afula, 1834111, Israel
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Ashkelon, 7830604, Israel
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Hadera, 3810101, Israel
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Petah Tikva, 4941492, Israel
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Rehovot, 7610001, Israel
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Safed, 1311001, Israel
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Tel Aviv, 64239, Israel
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Oslo, 0450, Norway
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Stavanger, Norway
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Krakow, 30-082, Poland
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Piotrkow Trybunalski, 97-635, Poland
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Szczecin, 70-965, Poland
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Warsaw, 04-635, Poland
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Wroclaw, 50-981, Poland
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Kristianstad, 29185, Sweden
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Lund, 222 21, Sweden
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Stockholm, 111 35, Sweden
Unknown Facility
Stockholm, 118 83, Sweden
Unknown Facility
Stockholm, Sweden
Related Publications (4)
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.
PMID: 22562554RESULTPitt 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.
PMID: 23713082RESULTOstrominski 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.
PMID: 40938666DERIVEDChung 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.
PMID: 33107592DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2011
First Posted
May 2, 2011
Study Start
May 9, 2011
Primary Completion
May 30, 2012
Study Completion
July 16, 2012
Last Updated
February 10, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.