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

Heart Failure Clinical Trial

— ARTS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345656
• Other study ID #: 14563
• Secondary ID: 2011-000301-45
• Status: Completed
• Phase: Phase 2
• Start date: May 9, 2011
• Est. completion date: July 16, 2012

Study information

• Verified date: January 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 457
• Est. completion date: July 16, 2012
• Est. primary completion date: May 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• BAY94-8862
Two 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks
• BAY94-8862
Four 1.25 mg BAY94-8862 tablets for duration of 4 weeks
• BAY94-8862
One 10 mg BAY94-8862 tablet for duration of 4 weeks
• 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
Placebo tablets for duration of 4 weeks
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Denmark,  Finland,  Germany,  Israel,  Norway,  Poland,  Sweden, 

References & Publications (2)

Pitt B, Filippatos G, Gheorghiade M, Kober L, Krum H, Ponikowski P, Nowack C, Kolkhof P, Kim SY, Zannad F. Rationale and design of ARTS: a randomized, double-blind study of BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic ki — View Citation

Pitt B, Kober L, Ponikowski P, Gheorghiade M, Filippatos G, Krum H, Nowack C, Kolkhof P, Kim SY, Zannad F. Safety and tolerability of the novel non-steroidal mineralocorticoid receptor antagonist BAY 94-8862 in patients with chronic heart failure and mild — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of serum potassium		4 weeks
Secondary	Change in serum magnesium		Day 8, Day 15, Day 22, Day 29
Secondary	Change in blood pressure		Day 8, Day 15, Day 22, Day 29
Secondary	Change in heart rate		Day 8, Day 15, Day 22, Day 29

External Links

•   Click here to find information about studies related to Bayer products conducted in Europe
•   Click here to find results for studies related to Bayer products