PK/PD Study of Subcutaneous Cenderitide Infusion in CHF Patients

NCT01316432 | Completed Phase 1

• 1 other identifier: NIL-CDNP-CT006
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 5

Brief Summary

The purposed of the study is to evaluate the pharmacokinetics (PK) response of continuous subcutaneous (SQ) infusion of cenderitide, as compared with a single SQ bolus.

Conditions

Heart Failure; ADHF; Chronic Heart Failure; CHF

Keywords

Cenderitide; CD-NP; Natriuretic peptide; Heart failure; Chronic heart failure; HF; CHF

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (PK)

  Pharmacokinetic measurements of subcutaneous cenderitide infusion compared with a subcutaneous bolus administration

  Up to 36 hours

Secondary Outcomes (1)

• Pharmacodynamics (PD)

  Up to 36 hours

Study Arms (3)

SQ Bolus Cenderitide

EXPERIMENTAL

Drug: Cenderitide

SQ Infusion Cenderitide

EXPERIMENTAL

24 hour SQ infusion of cenderitide

Drug: Cenderitide

Placebo

PLACEBO COMPARATOR

24 hrs of SQ placebo infusion

Other: Placebo

Interventions

Cenderitide DRUG

Cenderitide is a novel rationally designed chimeric natriuretic peptide to be administered in this trial as either a subcutaneous injection or infusion.

Also known as: CD-NP

SQ Bolus Cenderitide; SQ Infusion Cenderitide

Placebo OTHER

Placebo will be administered as a 24-hour SQ infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age.
• Documented systolic heart failure with ejection fraction (EF) ≤ 40%
• Clinical evidence of volume overload
• Systolic blood pressure ≥ 120 mmHg and ≤ 200 mmHg and diastolic blood pressure \> 60 mmHg and \< 110 mmHg at the time of screening.
• Stable doses of oral medication at least 24 hours prior to screening
• No known allergy or contraindication to furosemide (Lasix®)
• Female patients must be post-menopausal or surgically sterile. A woman may be considered to be surgically sterilized if she has had a bilateral tubal ligation (for at least 6 months), bilateral oophorectomy or complete hysterectomy.
• Be adequately informed of the nature and risks of the study and give written informed consent prior to receiving study medication.

You may not qualify if:

• Acute or suspected acute myocardial infarction (AMI) or troponin levels \> 5X the upper limit of normal at the institution's local laboratory and accompanied by dynamic ECG changes consistent with AMI
• Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to screening.
• Evidence of uncorrected volume or sodium depletion (NA ≤ 130) or other condition that would predispose the patient to adverse events.
• Clinically significant aortic or mitral valve stenosis.
• Temperature \> 38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment.
• ADHF associated with significant arrhythmias (ventricular tachycardia, bradyarrhythmias with ventricular rate \< 45 beats per minute or atrial fibrillation/flutter with ventricular response of \> 160 beats per minute).
• Severe renal failure defined as creatinine clearance \< 30 mL/min as estimated by both the Cockcroft-Gault and the Modification of Diet in Renal Disease (MDRD) equations.
• Significant pulmonary disease (history of oral daily steroid dependency, history of CO2 retention or need for intubation for acute exacerbation, or currently receiving IV steroids).
• Any organ transplant recipient, currently listed (anticipated in the next 60 days) for transplant, or admitted for cardiac transplantation.
• Major surgery within 30 days.
• Major neurologic event, including cerebrovascular events in the prior 60 days.
• Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns).
• Known hepatic impairment
• Received an investigational drug within 30 days prior to screening.
• Women who are pregnant or breastfeeding.

Sponsors & Collaborators

• Nile Therapeutics: lead
• Integrium: collaborator

Study Sites (5)

Orange County Research Center

Tustin, California, 92780, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Analab Clinical Research, Inc.

Lenexa, Kansas, 66219, United States

Location

Benchmark Research

Metairie, Louisiana, 70006, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

cenderitide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 16, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 18, 2012

Record last verified: 2012-10

Locations

US (5)