Safety Study of Cenderitide in Stable Chronic Heart Failure

Capricor Therapeutics

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Drug: Cenderitide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02359227

CDNP-578-01

Details and patient eligibility

About

Planned enrollment is approximately twelve subjects with stable chronic heart failure. Enrolled subjects will receive up to eight sequential days of continuous, stepwise, dose increasing, subcutaneous (SQ) infusions of open-label cenderitide via the Insulet Drug Delivery System. Planned infusion rates of cenderitide will be administered to subjects continuously during four, 48-hour infusion periods.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female, ≥ 18 years of age
• Body Mass Index (BMI) of 18-40 kg/m2, inclusive
• Current or historical New York Heart Association (NYHA) functional class ≥ II
• At least one of the following: documented systolic heart failure with an ejection fraction (EF) ≤ 40% and/or a historical measurement of plasma BNP ≥ 150 pg/mL (or NT-proBNP ≥ 600 pg/mL)
• Systolic blood pressure 100-160 mmHg
• Stable and compliant treatment with oral heart failure medications for at least 4 weeks prior to Screening

Key Exclusion Criteria:

• Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds
• Current clinical diagnosis of acute decompensated heart failure (ADHF)
• Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to Screening.
• Symptomatic postural hypotension
• Evidence of uncorrected volume or sodium ≤ 130 mmol/L or other condition that would predispose the patient to adverse events
• Clinically significant aortic or mitral valve stenosis
• Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
• Severe renal failure defined as creatinine clearance < 45 mL/min as estimated by either the Cockcroft-Gault or the MDRD equations
• Significant pulmonary disease (e.g., history of oral daily steroid dependency, history of Carbon Dioxide (CO2) retention or need for intubation for acute exacerbation, or currently receiving IV steroids)
• Known hepatic impairment as indicated by any of the following: A) total bilirubin > 3 mg/dL; B) albumin < 2.8 mg/dL, with other signs or symptoms of hepatic dysfunction; C) increased ammonia levels, if performed, with other signs or symptoms of hepatic dysfunction

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Cenderitide

Experimental group

Description:

Cenderitide will be administered as four, 48-hour, continuous, subcutaneous infusion rates of 0.5, 1.0, 2.0 and 3.0 ng/kg/min totaling up to eight sequential days of dosing.

Treatment:

Drug: Cenderitide