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PK/PD Study of Subcutaneous Cenderitide Infusion in CHF Patients

This study has been completed.
Sponsor:
Collaborator:
Integrium
Information provided by (Responsible Party):
Nile Therapeutics
ClinicalTrials.gov Identifier:
NCT01316432
First received: March 14, 2011
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Heart Failure
ADHF
Chronic Heart Failure
CHF
Drug: Cenderitide
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: A Study Assessing The Pharmacokinetics, Pharmacodynamics, Safety And Tolerability Of Subcutaneous Bolus And Subcutaneous Infusion Of Cenderitide In Patients With Chronic Heart Failure With Volume Overload (HF)

Resource links provided by NLM:


Further study details as provided by Nile Therapeutics:

Primary Outcome Measures:
  • Pharmacokinetics (PK) [ Time Frame: Up to 36 hours ] [ Designated as safety issue: No ]
    Pharmacokinetic measurements of subcutaneous cenderitide infusion compared with a subcutaneous bolus administration


Secondary Outcome Measures:
  • Pharmacodynamics (PD) [ Time Frame: Up to 36 hours ] [ Designated as safety issue: No ]
    Pharmacodynamics, safey and tolerability will be measured by BP, heart rate, and plasma cGMP after administration.


Enrollment: 58
Study Start Date: May 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SQ Bolus Cenderitide Drug: Cenderitide
Cenderitide is a novel rationally designed chimeric natriuretic peptide to be administered in this trial as either a subcutaneous injection or infusion.
Other Name: CD-NP
Experimental: SQ Infusion Cenderitide
24 hour SQ infusion of cenderitide
Drug: Cenderitide
Cenderitide is a novel rationally designed chimeric natriuretic peptide to be administered in this trial as either a subcutaneous injection or infusion.
Other Name: CD-NP
Placebo Comparator: Placebo
24 hrs of SQ placebo infusion
Other: Placebo
Placebo will be administered as a 24-hour SQ infusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds.
  • Any condition which, in the opinion of the Investigator, could interfere with, or for which the treatment might interfere with the conduct of the study, or which would unacceptably increase the risk of the patient's participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316432

Locations
United States, California
Orange County Research Center
Tustin, California, United States, 92780
United States, Florida
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
United States, Kansas
Analab Clinical Research, Inc.
Lenexa, Kansas, United States, 66219
United States, Louisiana
Benchmark Research
Metairie, Louisiana, United States, 70006
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Nile Therapeutics
Integrium
  More Information

No publications provided

Responsible Party: Nile Therapeutics
ClinicalTrials.gov Identifier: NCT01316432     History of Changes
Other Study ID Numbers: NIL-CDNP-CT006
Study First Received: March 14, 2011
Last Updated: October 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nile Therapeutics:
Cenderitide
CD-NP
Natriuretic peptide
Heart failure
Chronic heart failure
HF
CHF

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014