Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT02359227
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2015-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Cenderitide in Stable Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C575835', 'term': 'cenderitide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'dispFirstSubmitDate': '2020-02-06', 'completionDateStruct': {'date': '2015-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2015-02-02', 'dispFirstSubmitQcDate': '2020-02-06', 'studyFirstSubmitQcDate': '2015-02-04', 'dispFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability as assessed by changes in vital signs (blood pressure, heart rate, and body temperature), clinical laboratory tests, adverse events, 12-lead ECGs, and physical examinations compared to pre-dose, baseline measurements.', 'timeFrame': 'Measurements performed at regular intervals on Days 1-10, and at the safety follow-up visit (Day 16 ± 2 days).'}, {'measure': 'Pharmacokinetic (PK) profile of cenderitide as measured in area under the blood concentration-curve (AUC) from time zero to 48 hours post each infusion rate start, maximum blood concentration (Cmax), and time of maximum blood concentration (Tmax).', 'timeFrame': 'PK blood collection at regular intervals on Days 1-10.'}, {'measure': 'Pharmacodynamic (PD) response as assessed by changes in blood pressure, heart rate, weight, fluid balance (intake/output), plasma cGMP, ANP, NT-proBNP, and aldosterone, and urine cGMP compared to pre-dose baseline assessments.', 'timeFrame': 'PD assessments performed at regular intervals on Days 1-10, and at the safety follow-up visit (Day 16 ± 2 days).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Heart Failure', 'Natriuretic Peptides', 'Cenderitide'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Male or female, ≥ 18 years of age\n* Body Mass Index (BMI) of 18-40 kg/m2, inclusive\n* Current or historical New York Heart Association (NYHA) functional class ≥ II\n* 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)\n* Systolic blood pressure 100-160 mmHg\n* Stable and compliant treatment with oral heart failure medications for at least 4 weeks prior to Screening\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds\n* Current clinical diagnosis of acute decompensated heart failure (ADHF)\n* Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to Screening.\n* Symptomatic postural hypotension\n* Evidence of uncorrected volume or sodium ≤ 130 mmol/L or other condition that would predispose the patient to adverse events\n* Clinically significant aortic or mitral valve stenosis\n* Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)\n* Severe renal failure defined as creatinine clearance \\< 45 mL/min as estimated by either the Cockcroft-Gault or the MDRD equations\n* 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)\n* 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'}, 'identificationModule': {'nctId': 'NCT02359227', 'briefTitle': 'Safety Study of Cenderitide in Stable Chronic Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Capricor Inc.'}, 'officialTitle': 'A Study Assessing the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Open-Label, Continuous, Stepwise, Dose Increasing, Subcutaneous Infusion of Cenderitide Via the Insulet Drug Delivery System in Subjects With Stable, Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'CDNP-578-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cenderitide', 'description': '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.', 'interventionNames': ['Drug: Cenderitide']}], 'interventions': [{'name': 'Cenderitide', 'type': 'DRUG', 'description': 'Cenderitide is a dual receptor natriuretic peptide.', 'armGroupLabels': ['Cenderitide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}], 'overallOfficials': [{'name': 'Joel Neutel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orange County Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capricor Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}