Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT00074620
Status:
COMPLETED
Last Update Posted:
2007-10-05
First Post:
2003-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D006083', 'term': 'Graft Occlusion, Vascular'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C104614', 'term': 'polyethyleneglycol-hirudin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2006-01'}, 'lastUpdateSubmitDate': '2007-10-04', 'studyFirstSubmitDate': '2003-12-17', 'studyFirstSubmitQcDate': '2003-12-18', 'lastUpdatePostDateStruct': {'date': '2007-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft.'}], 'secondaryOutcomes': [{'measure': 'To determine the efficacy of PEG-hirudin compared to unfractionated heparin (UFH) on the frequency of vascular graft occlusions and on time to first graft occlusions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Haemodialysis', 'PEG-Hirudin', 'Vascular graft occlusion', 'Renal replacement therapy', 'Hemodialysis'], 'conditions': ['Chronic Kidney Failure', 'Vascular Graft Occlusion']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.kidney.org/', 'label': 'The National Kidney Foundation is a voluntary organisation which seeks to prevent kidney diseases, improve the health of patients and increase the availability of organs for transplantation'}, {'url': 'http://www.aakp.org/', 'label': 'The American Association of Kidney Patients helps kidney patients and their families deal with the physical, emotional and social impact of kidney diseases'}]}, 'descriptionModule': {'briefSummary': 'The study will look at the safety profile (unwanted effects) of the long-lasting anticoagulant PEG-hirudin (SPP200) and compare these unwanted effects to those of unfractionated heparin, commonly used in haemodialysis to avoid clotting of the graft and of the haemodialysis machine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Patients undergoing chronic haemodialysis via an arteriovenous graft\n* Arteriovenous graft in place for at least 3 months\n* Duration of haemodialysis of at least 3 months, with 3 full dialysis sessions per week with a duration between 2 and 5 hours per session\n* Women patients must be either postmenopausal for more than 1 year or, if of childbearing age, must use adequate contraception\n* Women patients must have a negative serum pregnancy test within one week of randomisation\n* Able to provide written informed consent prior to study participation'}, 'identificationModule': {'nctId': 'NCT00074620', 'briefTitle': 'A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Speedel Pharma Ltd.'}, 'officialTitle': 'A Randomised, Multicenter, Open-Label, Parallel Group Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Unfractionated Heparin as Anticoagulant Treatment in Patients Undergoing Haemodialysis Via an Arteriovenous Graft', 'orgStudyIdInfo': {'id': 'SPP200CRD01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PEG-hirudin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19106', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania Hospital - Franklin Dialysis Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jessica M Mann, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Speedel Bio Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Speedel Pharma Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}]}}}