BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease (ARTS)

Bayer

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Drug: Placebo; Drug: BAY94-8862; Drug: Spironolactone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01345656

14563

2011-000301-45 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 457 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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457 participants in 6 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Arm 2

Experimental group

Treatment:

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Arm 3

Experimental group

Treatment:

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Arm 4

Experimental group

Treatment:

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Arm 5

Placebo Comparator group

Treatment:

Drug: Placebo

Arm 6

Active Comparator group

Treatment:

Drug: Spironolactone