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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01345656
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : April 8, 2016
Information provided by (Responsible Party):

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Heart Failure Drug: BAY94-8862 Drug: Placebo Drug: Spironolactone Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Study Start Date : May 2011
Primary Completion Date : May 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: BAY94-8862
Two 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks
Experimental: Arm 2 Drug: BAY94-8862
Four 1.25 mg BAY94-8862 tablets for duration of 4 weeks
Experimental: Arm 3 Drug: BAY94-8862
One 10 mg BAY94-8862 tablet for duration of 4 weeks
Experimental: Arm 4 Drug: BAY94-8862
Part B only: Four 1.25 mg BAY94-8862 tablets in the morning and four tablets in the evening for duration of 4 weeks
Placebo Comparator: Arm 5 Drug: Placebo
Placebo tablets for duration of 4 weeks
Active Comparator: Arm 6 Drug: Spironolactone
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 Outcome Measures :
  1. Change of serum potassium [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 m2 </= eGFR (estimated Glomerular Filtration Rate) < 90 mL/min/1.73 m2 (MDRD, Modification of Diet in Renal Disease) at the screening visit
    • Part B: 30 mL/min/1.73 m2 </= eGFR <= 60 mL/min/1.73 m2 (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01345656

  Show 55 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications of Results:
Responsible Party: Bayer Identifier: NCT01345656     History of Changes
Other Study ID Numbers: 14563
2011-000301-45 ( EudraCT Number )
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016

Keywords provided by Bayer:
Chronic Heart Failure

Additional relevant MeSH terms:
Heart Failure
Kidney Diseases
Renal Insufficiency, Chronic
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents