Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-03-19 @ 3:47 PM
Study NCT ID:
NCT01736735
Status:
UNKNOWN
Last Update Posted:
2014-03-05
First Post:
2012-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Cross-Linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-03', 'studyFirstSubmitDate': '2012-11-26', 'studyFirstSubmitQcDate': '2012-11-28', 'lastUpdatePostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite endpoint comprised of: 6-Minute Walk Test, Body weight, KCCQ Score, Log2 NT-proBNP, time to first occurrence of heart/renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart/renal failure or death', 'timeFrame': 'Baseline, Week 8', 'description': 'Composite endpoint for the change from baseline to 8 weeks comprised of the following: 6-Minute Walk Test (6 MWT), Body weight, KCCQ Score, Log2 NT-proBNP, time to first occurrence of heart failure or renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart failure or renal failure, or death.'}], 'secondaryOutcomes': [{'measure': 'Change in 6-Minute Walk Test distance from baseline to Week 8.', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Time to heart failure or renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart failure or renal failure, or death', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Selected Inclusion Criteria:\n\n* Age 21 years or older at randomization\n* Heart failure with at least one of the following signs of current fluid overload:\n\n 1. Peripheral (or sacral) edema \\>1+ or ascites during screening or on day of randomization\n 2. Pulmonary congestion as determined by chest X-ray during the screening period\n* Ambulatory and able to perform the 6-minute walk test\n\nSelected Exclusion Criteria:\n\n* Participation in another clinical trial of an investigational or marketed drug within 30 days or 5 half-lives (whichever is longer) preceding screening\n* Any hospitalization or unscheduled outpatient decongestion therapy using IV diuretics, ultrafiltration, or paracentesis within 8 weeks prior to or during screening\n* Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 2 months prior to or during screening or anticipated need during study participation\n* Heart transplant recipient, or anticipated need for transplant or LVAD during study participation\n* Any of the following events having occurred within 8 weeks prior to or during screening: myocardial infarction, transient ischemic attack, stroke, or acute coronary syndrome as judged by the Investigator'}, 'identificationModule': {'nctId': 'NCT01736735', 'acronym': 'STEPWISE', 'briefTitle': 'Evaluation of Cross-Linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sorbent Therapeutics'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Multi-center Study Comparing Cross-linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects', 'orgStudyIdInfo': {'id': 'CTST-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CLP', 'description': 'CLP BID', 'interventionNames': ['Drug: CLP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'BID powder', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'CLP', 'type': 'DRUG', 'armGroupLabels': ['CLP']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92780', 'city': 'Tustin', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joel Neutel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orange Country Research Center', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Ashkelon', 'status': 'RECRUITING', 'country': 'Israel', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}], 'centralContacts': [{'name': 'Jade Brennan', 'role': 'CONTACT', 'email': 'jadebrennan@momentum-research.com', 'phone': '919-491-5721'}, {'name': 'Jean Chang', 'role': 'CONTACT', 'email': 'jchang@sorbent.com'}], 'overallOfficials': [{'name': 'Howard Dittrich, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sorbent Therapeutics, Study Sponsor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorbent Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}