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

A randomized, double-blind, multi-center study to assess safety and tolerability of different oral doses of BAY 94-8862 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) - ARTS study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000301-45-FI

Enrollment

425

Registered

2011-03-21

Start date

2011-05-04

Completion date

Unknown

Last updated

2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable chronic heart failure subjects with left ventricular systolic dysfunction and mild (Part A) or moderate (Part B) chronic kidney disease MedDRA version: 14.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: BAY 94-8862 IR tablet 1.25 mg Product Code: BAY 94-8862 coated tablet 1.25 mg Pharmaceutical Form: Film-coated tablet CAS Number: 1050477-31-0 Current Sponsor code: BAY 94-8862 micronize

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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 2. 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 3. Known kidney damage for >/= 3 months, as defined by structural or functional abnormalities of the kidney, and -- Part A: 60 mL/min/1.73 m2 /= 90 mmHg without signs or symptoms of hypotension at the screening visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 340

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (Part B only) 2. Subjects with anuria, acute renal failure, or Addison’s disease 3. Acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization 4. Valvular heart disease requiring surgical intervention during the course of the study 5. History of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: Part A The safety and tolerability of 3 oral doses of BAY 94 8862 given once daily over 4 weeks in a randomized, placebo-controleld, double-blind study in subjects with chronic heart failure (CHF) with left ventricular systolic dysfunction (LVSD) and mild chronic kidney disease (CKD) (60 mL/min/7.73 m2 => eGFR <90 mL/min/1.73 m2). the effects on serum potassium, the effects of these doses on the change in biomarkers of renal function, eGFR using the Modification of Diet in Renal Disease Study Group (MDRD) formula, albuminuria, and pharmacokinetics of BAY 94 8862 and its metabolites in plasma after multiple oral doses. Part B To investigate the change of serum potassium after treatment with 4 oral dosages of BAY 94 8862 given once or twice daily over 4 weeks in a randomized, placebo-controlled, double-blind study design versus placebo in subjects with CHF with LVSD adn moderate CKD (30 mL/min/1.73 m2=<eGFR=<60 mL/min/1.73 m2).;Secondary Objective: Secondary objectives of Part B of the study are: To investigate the change of serum potassium after treatment with 4 oral dosages of BAY 94 8862 given once or twice daily over 4 weeks versus the active comparator spironolactone in subjects with CHF with LVSD and moderate CKD (30 mL/min/1.73 m2 =< eGFR =<60 mL/min/1.73 m2). To assess safety and tolerability of these doses, the effect on cardiac function by changes in concentrations of various biomarkers, and the change in biomarkers of renal function, eGFR (MDRD), and albuminuria. In addition, pharmacokinetics of BAY 94 8862 and its metabolites in plasma after multiple oral doses will be assessed. ;Primary end point(s): Change in serum potassium ;Timepoint(s) of evaluation of this end point: 4 weeks	—

Measure

Time frame

Main Objective: Part A The safety and tolerability of 3 oral doses of BAY 94 8862 given once daily over 4 weeks in a randomized, placebo-controleld, double-blind study in subjects with chronic heart failure (CHF) with left ventricular systolic dysfunction (LVSD) and mild chronic kidney disease (CKD) (60 mL/min/7.73 m2 => eGFR <90 mL/min/1.73 m2). the effects on serum potassium, the effects of these doses on the change in biomarkers of renal function, eGFR using the Modification of Diet in Renal Disease Study Group (MDRD) formula, albuminuria, and pharmacokinetics of BAY 94 8862 and its metabolites in plasma after multiple oral doses. Part B To investigate the change of serum potassium after treatment with 4 oral dosages of BAY 94 8862 given once or twice daily over 4 weeks in a randomized, placebo-controlled, double-blind study design versus placebo in subjects with CHF with LVSD adn moderate CKD (30 mL/min/1.73 m2=<eGFR=<60 mL/min/1.73 m2).;Secondary Objective: Secondary objectives of Part B of the study are: To investigate the change of serum potassium after treatment with 4 oral dosages of BAY 94 8862 given once or twice daily over 4 weeks versus the active comparator spironolactone in subjects with CHF with LVSD and moderate CKD (30 mL/min/1.73 m2 =< eGFR =<60 mL/min/1.73 m2). To assess safety and tolerability of these doses, the effect on cardiac function by changes in concentrations of various biomarkers, and the change in biomarkers of renal function, eGFR (MDRD), and albuminuria. In addition, pharmacokinetics of BAY 94 8862 and its metabolites in plasma after multiple oral doses will be assessed. ;Primary end point(s): Change in serum potassium ;Timepoint(s) of evaluation of this end point: 4 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Change in serum magnesium , change in blood pressure, change in heart rate;Timepoint(s) of evaluation of this end point: Day 8, Day 15, Day 22, Day 29	—

Countries

Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Israel, Norway, Poland, Sweden

Contacts

Public ContactBayer Clinical Trials Contact

Bayer Healthcare AG

clinical-trials-contact@bayerhealthcare.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026