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Completed

NCT Number: NCT01345656

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Graz, Styria, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY94-8862

Drug

Two 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks

Placebo

Drug

Placebo tablets for duration of 4 weeks

Spironolactone

Drug

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

Primary outcomes

  1. Change of serum potassium

    Time frame: 4 weeks

Secondary outcomes

  1. Change in serum magnesium

    Time frame: Day 8, Day 15, Day 22, Day 29

  2. Change in blood pressure

    Time frame: Day 8, Day 15, Day 22, Day 29

  3. Change in heart rate

    Time frame: Day 8, Day 15, Day 22, Day 29

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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)

Acronym: ARTS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 2, 2011
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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