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

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Drug: BAY94-8862; Drug: Placebo; Drug: Spironolactone

• Registration Number: NCT01345656
• Lead Sponsor: Bayer

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Study Start: 2011-05-09
• Primary Completion: 2012-05-30
• Study Completion: 2012-07-16
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 457

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	BAY94-8862	-
Arm 4	BAY94-8862	-
Arm 5	Placebo	-
Arm 2	BAY94-8862	-
Arm 3	BAY94-8862	-
Arm 6	Spironolactone	-

Primary Outcome Measures

Name	Time	Method
Change of serum potassium	4 weeks

Secondary Outcome Measures

Name	Time	Method
Change in serum magnesium	Day 8, Day 15, Day 22, Day 29
Change in blood pressure	Day 8, Day 15, Day 22, Day 29
Change in heart rate	Day 8, Day 15, Day 22, Day 29