Trial Condition(s):

Heart Failure

BAY94-8862 dose finding trial in subjects with chronic heart failure and mild (Part A) or moderate (Part B) chronic kidney disease (ARTS)

Bayer Identifier:

14563

ClinicalTrials.gov Identifier:

NCT01345656

EudraCT Number:

2011-000301-45

Study Completed

Trial Purpose

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

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Summary

Enrollment Goal
457
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Wroclaw, Poland, 50-981

Status
Completed
 
Locations

Investigative Site

Helsinki, Finland, FIN-00260

Status
Completed
 
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Investigative Site

Turku, Finland, FIN-20520

Status
Completed
 
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Investigative Site

Jyväskylä, Finland, FI-40620

Status
Completed
 
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Investigative Site

Stavanger, Norway

Status
Completed
 
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Investigative Site

Oslo, Norway, 0450

Status
Completed
 
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Investigative Site

Frankfurt, Germany, 60596

Status
Completed
 
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Investigative Site

Köln, Germany, 50968

Status
Completed
 
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Investigative Site

Wedel, Germany, 22880

Status
Completed
 
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Investigative Site

Krakow, Poland, 30-082

Status
Completed
 
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Investigative Site

Stockholm, Sweden, 111 35

Status
Completed
 
Locations

Investigative Site

Lund, Sweden, 222 21

Status
Completed
 
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Investigative Site

Kristianstad, Sweden, 29185

Status
Completed
 
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Investigative Site

Copenhagen Ø, Denmark, 2100

Status
Completed
 
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Investigative Site

Hellerup, Denmark, 2900

Status
Completed
 
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Investigative Site

København NV, Denmark, 2400

Status
Completed
 
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Investigative Site

Hvidovre, Denmark, 2650

Status
Completed
 
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Investigative Site

Herlev, Denmark, 2730

Status
Completed
 
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Investigative Site

Svendborg, Denmark, 5700

Status
Completed
 
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Investigative Site

Odense, Denmark, 5000

Status
Completed
 
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Investigative Site

Zefat, Israel, 1311001

Status
Completed
 
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Investigative Site

Ashkelon, Israel, 7830604

Status
Completed
 
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Investigative Site

Petah Tikva, Israel, 4941492

Status
Completed
 
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Investigative Site

Rehovot, Israel, 7610001

Status
Completed
 
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Investigative Site

Graz, Austria, 8036

Status
Completed
 
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Investigative Site

Wien, Austria, 1100

Status
Completed
 
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Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
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Investigative Site

Warszawa, Poland, 04-635

Status
Completed
 
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Investigative Site

Piotrkow Trybunalski, Poland, 97-635

Status
Completed
 
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Investigative Site

Szczecin, Poland, 70-965

Status
Completed
 
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Investigative Site

Stockholm, Sweden

Status
Completed
 
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Investigative Site

Linz, Austria, 4010

Status
Completed
 
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Investigative Site

Brno, Czech Republic, 625 00

Status
Completed
 
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Investigative Site

Praha 2, Czech Republic, 12808

Status
Completed
 
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Investigative Site

Praha 5, Czech Republic, 15030

Status
Completed
 
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Investigative Site

Liberec, Czech Republic, 460 63

Status
Completed
 
Locations

Investigative Site

BRASSCHAAT, Belgium, 2930

Status
Completed
 
Locations

Investigative Site

ROESELARE, Belgium, 8800

Status
Completed
 
Locations

Investigative Site

Erfurt, Germany, 99084

Status
Completed
 
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Investigative Site

Køge, Denmark, 4600

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 13353

Status
Completed
 
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Investigative Site

Hadera, Israel, 3810101

Status
Completed
 
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Investigative Site

Tel Aviv, Israel, 64239

Status
Completed
 
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Investigative Site

Afula, Israel, 1834111

Status
Completed
 
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Investigative Site

Wermsdorf, Germany, 04779

Status
Completed
 
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Investigative Site

Dresden, Germany, 01277

Status
Completed
 
Locations

Investigative Site

Stockholm, Sweden, 118 83

Status
Completed
 
Locations

Investigative Site

Frederiksberg, Denmark, 2000

Status
Completed
 
Locations

Investigative Site

Viborg, Denmark, 8800

Status
Completed
 
Locations

Investigative Site

Esbjerg, Denmark, 6700

Status
Completed
 

Trial Design