Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT00264693
Status:
COMPLETED
Last Update Posted:
2010-01-26
First Post:
2005-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-25', 'studyFirstSubmitDate': '2005-12-11', 'studyFirstSubmitQcDate': '2005-12-11', 'lastUpdatePostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Renal Insufficiency']}, 'referencesModule': {'references': [{'pmid': '19685350', 'type': 'BACKGROUND', 'citation': 'Schmid P, Fischer AG, Wuillemin WA. Low-molecular-weight heparin in patients with renal insufficiency. Swiss Med Wkly. 2009 Aug 8;139(31-32):438-52. doi: 10.4414/smw.2009.11284.'}, {'pmid': '19175499', 'type': 'RESULT', 'citation': 'Schmid P, Brodmann D, Fischer AG, Wuillemin WA. Study of bioaccumulation of dalteparin at a prophylactic dose in patients with various degrees of impaired renal function. J Thromb Haemost. 2009 Apr;7(4):552-8. doi: 10.1111/j.1538-7836.2009.03292.x. Epub 2009 Jan 19.'}, {'pmid': '19624460', 'type': 'RESULT', 'citation': 'Schmid P, Brodmann D, Odermatt Y, Fischer AG, Wuillemin WA. Study of bioaccumulation of dalteparin at a therapeutic dose in patients with renal insufficiency. J Thromb Haemost. 2009 Oct;7(10):1629-32. doi: 10.1111/j.1538-7836.2009.03556.x. Epub 2009 Jul 17.'}, {'pmid': '20088934', 'type': 'RESULT', 'citation': 'Schmid P, Brodmann D, Fischer AG, Wuillemin WA. Prospective observational cohort study of bioaccumulation of dalteparin at a prophylactic dose in patients with peritoneal dialysis. J Thromb Haemost. 2010 Apr;8(4):850-2. doi: 10.1111/j.1538-7836.2010.03749.x. Epub 2010 Jan 17. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.ksl.ch/standorte/luzern/kliniken/medizin/haematologie.html', 'label': 'Luzerner Kantonsspital, Hematology'}, {'url': 'http://www.ksl.ch/standorte/luzern/kliniken/medizin/nephrologie.html', 'label': 'Luzerner Kantonsspital, Nephrology'}, {'url': 'http://www.pirmin-schmid.ch', 'label': 'Pirmin Schmid'}]}, 'descriptionModule': {'briefSummary': 'Low molecular weight heparins (LMWH) have been shown to be at least as efficient and safe as unfractioned heparin (UFH) in prophylaxis and treatment of venous thromboembolic events and in therapy of acute cardiovascular diseases. LMWH are widely used as safe replacement of oral anticoagulation with vitamin K antagonists (VKA).\n\nDue to their pharmacokinetic characteristics, LMWH tend to accumulate in patients with impaired renal function. Official guidelines recommend therefore to use LMWH controlled by Anti-Xa levels or to use UFH instead of LMWH to provide full therapeutic anticoagulation therapy in patients with severe renal insufficiency.\n\nAlthough dosage recommendations have been proposed for enoxaparin in patients with renal impairment based on several studies, these data cannot be applied to other LMWH directly due to different pharmacokinetic properties of each drug.\n\nThe present study aims to clarify the pharmacokinetics of dalteparin in patients with renal insufficiency, especially addressing the question of accumulation after multiple doses and including patients with severe renal insufficiency and derive a safe and suitable concept for using dalteparin in patients with impaired renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of a medical and surcigal department with all levels of renal function who needs Dalteparin for prophylaxis or therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient starting with dalteparin for prophylaxis OR therapy by order of the treating physician (after having evaluated clinical indication and contraindications).\n* Renal function normal OR impaired with or without dialysis therapy according to open study groups\n* Age \\>= 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy / Lactation\n* Dalteparin or other LMWH already in use for \\> 1 day, unless just in use during hemodialysis\n* Anti-Xa level before first application of dalteparin \\> 0.3 U / ml\n* Participation in another study\n* Anuria OR glomerular filtration rate \\< 10 ml/min without dialysis\n* Patient on intensive care unit (ICU)\n* Cardiovascular unstable patient or probable need for a quick stop of anticoagulation (e.g. emergency surgery)\n* Patient with a disease whose estimated life expectancy is \\< 28 days'}, 'identificationModule': {'nctId': 'NCT00264693', 'briefTitle': 'Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function', 'organization': {'class': 'OTHER', 'fullName': 'Luzerner Kantonsspital'}, 'officialTitle': 'Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function', 'orgStudyIdInfo': {'id': 'LMWHplus 3'}, 'secondaryIdInfos': [{'id': 'Ethikkommission Luzern 542'}, {'id': 'KSL 2006-1H'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'P - A', 'description': 'Prophylactic Dosage, GFR \\>= 60 mL/min/1.73m\\^2'}, {'label': 'P - B', 'description': 'Prophylactic Dosage, GFR 30-59 mL/min/1.73m\\^2'}, {'label': 'P - C', 'description': 'Prophylactic Dosage, GFR \\< 30 mL/min/1.73m\\^2'}, {'label': 'P - CAPD', 'description': 'Prophylactic Dosage, CAPD'}, {'label': 'T - A', 'description': 'Therapeutic Dosage, GFR \\>= 60 mL/min/1.73m\\^2'}, {'label': 'T - B', 'description': 'Therapeutic Dosage, GFR 30-59 mL/min/1.73m\\^2'}, {'label': 'T - C', 'description': 'Therapeutic Dosage, GFR \\< 30 mL/min/1.73m\\^2'}, {'label': 'T - CAPD', 'description': 'Therapeutic Dosage, CAPD'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Lucerne', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Kantonsspital Luzern', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'overallOfficials': [{'name': 'Pirmin Schmid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luzerner Kantonsspital, Hematology'}, {'name': 'Andreas G Fischer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Luzerner Kantonsspital, Nephrology'}, {'name': 'Walter A Wuillemin, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Luzerner Kantonsspital, Hematology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luzerner Kantonsspital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'W.A. Wuillemin, MD PhD', 'oldOrganization': 'Head, Division of Hematology and Hematology Central Laboratory, Kantonsspital Luzern, Luzern, Switzerland'}}}}