Safety Study of Cenderitide in Chronic Stable Heart Failure With Moderate Renal Impairment
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/11/2018 |
| Start Date: | December 2015 |
| End Date: | March 31, 2016 |
A Randomized, Double Blind, Placebo-Controlled, Dose Escalating, Cross Over Designed Study to Assess the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Open-Label, Continuous Subcutaneous Infusion of Cenderitide Via the Insulet Drug Delivery System in Chronic Stable Heart Failure Subjects With Moderate Renal Impairment
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.
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.
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
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