Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-25 @ 6:10 PM
Study NCT ID:
NCT04558892
Status:
TERMINATED
Last Update Posted:
2023-01-30
First Post:
2020-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009404', 'term': 'Nephrotic Syndrome'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D009401', 'term': 'Nephrosis'}, {'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': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'whyStopped': 'The primary objectives were achieved.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2020-09-16', 'lastUpdatePostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Venous thromboembolic events.', 'timeFrame': 'Follow-up period of 1 year from enrollment.', 'description': 'Clinically overt episode of VTE.'}, {'measure': 'Adverse events of enoxaparin.', 'timeFrame': 'Follow-up period of 1 year from enrollment.', 'description': 'Episodes of minor and major bleeding or heparin-induced thrombocytopenia.'}], 'primaryOutcomes': [{'measure': "Therapeutic enoxaparin's anti-Xa activity in nephrotic syndrome.", 'timeFrame': 'Average: Day 3-5', 'description': 'Anti-Xa activity values ≥ 0.3 IU/mL in the steady state of enoxaparin concentration, on average between days 3 and 5.'}, {'measure': "Minimum threshold of enoxaparin's anti-Xa activity.", 'timeFrame': 'Average: Day 3-5', 'description': 'Anti-Xa activity values ≥ 0.2 IU/mL in the steady state of enoxaparin concentration on average between days 3 and 5.'}], 'secondaryOutcomes': [{'measure': 'Severity of nephrotic syndrome.', 'timeFrame': 'Day 0, Day 3-5', 'description': 'Serum or/and urinary concentration of laboratory markers of disease.'}, {'measure': 'Coagulation system protein.', 'timeFrame': 'Day 0, Day 3-5', 'description': 'Plasma concentration or activity of secondary hemostasis system protein (clotting factors, fibrinolysis factors, regulatory molecules).'}, {'measure': 'Renal function.', 'timeFrame': 'Day 0, Day 3-5', 'description': 'Estimated glomerular filtration rate (eGFR) calculated with simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula.'}, {'measure': 'Edema.', 'timeFrame': 'Day 0, Day 3-5', 'description': 'Clinical evaluation of edema using 3-stages scale (I: \\<5 kg, II: 5-10 kg, III: \\>10 kg) at enrollment and on the day of measuring anti-Xa activity of enoxaparin.'}, {'measure': 'Overhydration.', 'timeFrame': 'Day 3-5', 'description': 'Overhydration measured by bioimpedance spectroscopy on the day of measuring anti-Xa activity of enoxaparin.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nephrotic syndrome', 'Enoxaparin', 'Low molecular weight heparin', 'Anti-Xa activity', 'Antifactor Xa', 'Venous thromboembolism'], 'conditions': ['Nephrotic Syndrome']}, 'referencesModule': {'references': [{'pmid': '34884411', 'type': 'RESULT', 'citation': 'Matyjek A, Rymarz A, Nowicka Z, Literacki S, Rozmyslowicz T, Niemczyk S. Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome-A Single Center Prospective Study. J Clin Med. 2021 Dec 6;10(23):5709. doi: 10.3390/jcm10235709.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to test the hypothesis that enoxaparin efficacy is reduced in severe nephrotic syndrome. Another purpose is to compare two dosing regimens.', 'detailedDescription': 'Nephrotic syndrome (NS) is a rare clinical condition characterized by proteinuria exceeding \\>3.5 g/24h, hypoalbuminemia, dyslipidemia and edema and is associated with hypercoagulable state. In severe cases, with serum albumin ≤2.5 g/dL, the risk of venous thromboembolic events (VTE) is particularly high, and pharmacological prophylaxis is recommended. However, there is a limited evidence of its efficacy and optimal dosing.\n\nThe study is designed as 3 arms clinical trial, with 2 study groups and a single control group. The study groups will include patients with severe NS parallelly, alternately assigned (1:1) into two enoxaparin dosing regimens. The control group will consisted of individuals without proteinuria and edema, similar in terms of age, anthropometric features and renal function to NS patients, who will be administered a standard enoxaparin dose. A peak anti-Xa activity at the steady state will be measured to determine the plasma concentration of enoxaparin. Additional laboratory tests for markers of NS severity, renal function and coagulation system proteins will be performed. The overhydration and body water compartments will be assessed using bioimpedance spectroscopy technique. Nephrotic patients will be followed up by 12 months to assess overt VTE and adverse events associated with enoxaparin use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe NS, defined as proteinuria exceeding 3.5 g/24h or 50 mg/kg/24h and serum albumin ≤2.5 g/dL;\n* eGFR ≥30 mL/min/1.73 m2.\n\nExclusion Criteria:\n\n* Body mass index (BMI) ≥40 kg/m2;\n* Low body mass (\\<45 kg for female, \\<57 kg for male);\n* Acute VTE;\n* Previously introduced anticoagulation (due to comorbidities);\n* Contraindications for enoxaparin;\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT04558892', 'acronym': 'ENOX-inNS', 'briefTitle': 'Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Military Institute od Medicine National Research Institute'}, 'officialTitle': "Assessment of Coagulation Disorders and of Enoxaparin's Anti-Xa Activity, When Used for Thromboprophylaxis, in Severe Nephrotic Syndrome.", 'orgStudyIdInfo': {'id': '5/8952 (443)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nephrotic syndrome - fixed dose (NS-FD)', 'description': 'Drug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously.', 'interventionNames': ['Drug: Enoxaparin']}, {'type': 'EXPERIMENTAL', 'label': 'Nephrotic syndrome - adjusted dose (NS-AD)', 'description': 'Drug: Enoxaparin; Dose: 1 mg/kg of ideal body weight; Administration: once daily subcutaneously.', 'interventionNames': ['Drug: Enoxaparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control - fixed dose (C-FD)', 'description': 'Drug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously.', 'interventionNames': ['Drug: Enoxaparin']}], 'interventions': [{'name': 'Enoxaparin', 'type': 'DRUG', 'armGroupLabels': ['Control - fixed dose (C-FD)', 'Nephrotic syndrome - adjusted dose (NS-AD)', 'Nephrotic syndrome - fixed dose (NS-FD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04-141', 'city': 'Warsaw', 'state': 'Masovian District', 'country': 'Poland', 'facility': 'Military Institute of Medicine', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Anna Matyjek, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Military Institute of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Military Institute od Medicine National Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna Matyjek', 'investigatorAffiliation': 'Military Institute od Medicine National Research Institute'}}}}