Safety Study of Cenderitide in Stable Chronic Heart Failure

NCT ID: NCT02359227

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-04-02

Brief Summary

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cenderitide

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.

Group Type: EXPERIMENTAL

Cenderitide

Intervention Type: DRUG

Cenderitide is a dual receptor natriuretic peptide.

Interventions

Cenderitide

Cenderitide is a dual receptor natriuretic peptide.

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capricor Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel Neutel, MD

Role: PRINCIPAL_INVESTIGATOR

Orange County Research Center

Locations

Orange County Research Center

Tustin, California, United States

Countries

United States

Other Identifiers

CDNP-578-01

Identifier Type: -

Identifier Source: org_study_id