Safety Study of Cenderitide in Chronic Stable Heart Failure With Moderate Renal Impairment

Capricor Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Renal Insufficiency; Heart Failure

Treatments: Drug: Placebo; Drug: Cenderitide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02603614

CDNP-578-02

Details and patient eligibility

About

CNDP-578-02 is a randomized, double-blind, placebo-controlled, dose-escalation, crossover design trial. Eight evaluable subjects (n=8) with chronic stable heart failure and moderate renal impairment will be randomized (1:1) to receive cenderitide or placebo. Enrolled subjects will begin with Infusion Period A where they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo via the Insulet Drug Delivery System. Enrolled subjects will then cross over into Infusion Period B where they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to provide written informed consent after reviewing the design and risks of the study and prior to completing any study-related procedure
• Willing and able to understand and comply with all study procedures and requirements, including in-patient stay
• Current or historical New York Heart Association (NYHA) functional class ≥ II
• Glomerular Filtration Rate (GFR) ≥ 30 and ≤ 60 mL/min at the time of screening
• Systolic blood pressure 120-160 mmHg at the time of screening
• Stable and compliant treatment with oral medications for at least 4 weeks prior to screening
• Body Mass Index (BMI) ≥18 and ≤45 kg/m2 at the time of screening
• Women of child bearing potential (WOCBP) and males must agree to use at least two forms of contraception, of which one includes a barrier method (male condom) by the male partner, during study participation and continued for at least 90 days after the conclusion of the final infusion rate. In addition, sperm donations by male subjects are not permitted during the subject's participation in the research study and for at least 90 days after the conclusion of the final infusion rate. This criterion may be waived for male subjects who have undergone a vasectomy at least 6 months prior to screening
• Willing and able to abstain from drugs, alcohol, and tobacco during study participation

Exclusion criteria

• Hypersensitivity or allergy to natriuretic peptides
• Acute decompensated heart failure (ADHF) within 30 days prior to randomization
• Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to randomization
• Symptomatic postural hypotension
• Concomitant medication of an aldosterone blocker (e.g., eplerenone or spironolactone) within 30 days prior to randomization
• Potassium of ≥ 5.0 mmol/L
• Evidence of uncorrected volume or sodium ≤ 130 mmol/L within 24 hours prior to randomization
• Clinically significant aortic or mitral valve stenosis
• Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
• Significant pulmonary disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups

Cenderitide-Placebo

Experimental group

Description:

Infusion Period A: Cenderitide Infusion Period B: Placebo This is a randomized, double-blind, placebo-controlled, cross-over trial. The sequence was either cenderitide crossed over to placebo or placebo crossed over to cenderitide, with the sequence divided into two 7-day infusion periods (Infusion Period A and Infusion Period B).

Treatment:

Drug: Placebo

Drug: Cenderitide

Placebo-Cenderitide

Experimental group

Description:

Infusion Period A: Placebo Infusion Period B: Cenderitide This is a randomized, double-blind, placebo-controlled, cross-over trial. The sequence was either cenderitide crossed over to placebo or placebo crossed over to cenderitide, with the sequence divided into two 7-day infusion periods (Infusion Period A and Infusion Period B).

Treatment:

Drug: Placebo

Drug: Cenderitide