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 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)

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