Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01179620
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2010-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Certoparin in Renal Patients Undergoing Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C403769', 'term': 'certoparin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-09', 'studyFirstSubmitDate': '2010-07-27', 'studyFirstSubmitQcDate': '2010-08-10', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients requiring uptitration', 'timeFrame': 'Week 8'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of Certoparin', 'timeFrame': 'Day 1, Week 4'}, {'measure': 'Safety and tolerability of Certoparin', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'keywords': ['Hemodialysis, Certoparin'], 'conditions': ['Renal Dialysis']}, 'referencesModule': {'references': [{'pmid': '22742742', 'type': 'DERIVED', 'citation': 'Dorsch O, Krieter DH, Lemke HD, Fischer S, Melzer N, Sieder C, Bramlage P, Harenberg J. A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis--the membrane study. BMC Nephrol. 2012 Jun 28;13:50. doi: 10.1186/1471-2369-13-50.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy, safety and pharmacokinetics of certoparin when used to prevent clotting during hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring hemodialysis\n* Patients requiring anticoagulation therapy during hemodialysis\n* Written informed consent\n\nExclusion Criteria:\n\n* Hypersensitivity to study medication\n* Genetic abnormality or disease of clotting system\n* Prior major surgery or bleeding\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01179620', 'acronym': 'MEMBRANE', 'briefTitle': 'Certoparin in Renal Patients Undergoing Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-center, Prospective, Open-label, 8-weeks Study to Investigate the Efficacy, Safety and Pharmacokinetics of Certoparin (3000 IU Anti-Xa Bolus, With the Option to Titrate Dose)in the Prophylaxis of Clotting in the Extracorporeal Circuit in Patients Undergoing Chronic Hemodialysis', 'orgStudyIdInfo': {'id': 'CMEX839BDE06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Certoparin', 'interventionNames': ['Drug: Certoparin']}], 'interventions': [{'name': 'Certoparin', 'type': 'DRUG', 'description': 'Certoparin', 'armGroupLabels': ['Certoparin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Novartis Investigative Site Darmstadt', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'city': 'Elsenfeld', 'country': 'Germany', 'facility': 'Novartis Investigative Site Elsenfeld', 'geoPoint': {'lat': 49.84289, 'lon': 9.16355}}, {'city': 'Flensburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site Flensburg', 'geoPoint': {'lat': 54.78805, 'lon': 9.43722}}, {'city': 'Heringen', 'country': 'Germany', 'facility': 'Novartis Investigative Site Heringen', 'geoPoint': {'lat': 50.88798, 'lon': 10.00717}}, {'city': 'Hoyerswerda', 'country': 'Germany', 'facility': 'Novartis Investigative Site Hoyerswerda,', 'geoPoint': {'lat': 51.43787, 'lon': 14.23549}}, {'city': 'Kronach', 'country': 'Germany', 'facility': 'Novartis Investigative Site Kronach', 'geoPoint': {'lat': 50.23963, 'lon': 11.33308}}, {'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'München', 'country': 'Germany', 'facility': 'Novartis Investigative Site München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Novartis Investigative Site Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}