Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-02-20 @ 12:41 PM
Study NCT ID:
NCT01761994
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2012-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Nafamostat Mesilate in Prolonging Filter Patency With Patients on Continuous Renal Replacement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C032855', 'term': 'nafamostat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-03', 'studyFirstSubmitDate': '2012-12-24', 'studyFirstSubmitQcDate': '2013-01-03', 'lastUpdatePostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '2 years', 'description': 'Mortality in intensive care unit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nafamostat mesilate', 'heparin', 'continuous renal replacement therapy'], 'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '33314078', 'type': 'DERIVED', 'citation': 'Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.'}, {'pmid': '25302581', 'type': 'DERIVED', 'citation': 'Lee YK, Lee HW, Choi KH, Kim BS. Ability of nafamostat mesilate to prolong filter patency during continuous renal replacement therapy in patients at high risk of bleeding: a randomized controlled study. PLoS One. 2014 Oct 10;9(10):e108737. doi: 10.1371/journal.pone.0108737. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'Continuous renal replacement therapy (CRRT) has been considered as an effective modality for renal replacement therapy in hemodynamically unstable patients within intensive care unit (ICU) except for the necessity of anticoagulation. The severity and peculiarities of ICU patients often make it equivocal to use anticoagulation. This is a prospective randomized controlled study to show the difference in filter life span and adverse event between HF1000 (nafamostat mesilate) group and M100 (heparin-free) group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who have at least one of the hemorrhagic tendencies of following conditions and needs CRRT hemodynamically;\n\n 1. Platelet count \\< 100,000\n 2. aPTT \\> 60 sec\n 3. PT-INR \\> 2.0\n 4. active hemorrhage\n 5. surgery within 48 hours\n 6. cerebral hemorrhage within 3 months or history of major bleeding\n 7. septic shock or DIC.\n\nExclusion Criteria:\n\n* pregnancy, breast feeding, possibility of pregnancy,\n* allergy to nafamostat mesilate,\n* other conditions that physician consider unfit for candidate.'}, 'identificationModule': {'nctId': 'NCT01761994', 'briefTitle': 'The Effect of Nafamostat Mesilate in Prolonging Filter Patency With Patients on Continuous Renal Replacement Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2007-0220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'M100', 'description': 'heparin free CRRT group', 'interventionNames': ['Drug: Anticoagulation with nafamostat mesilate']}, {'type': 'EXPERIMENTAL', 'label': 'HF1000', 'description': 'CRRT with nafamostat mesilate anticoagulation group', 'interventionNames': ['Drug: Anticoagulation with nafamostat mesilate']}], 'interventions': [{'name': 'Anticoagulation with nafamostat mesilate', 'type': 'DRUG', 'otherNames': ['futhan'], 'description': "Initial dose of nafamostat mesilate is 20mg/hr. Dosage is adjusted from 10mg to 30mg/hr according to patients' status. For priming, two vial of nafamostat mesilate was dissolved in 2mL of 5% glucose fluid, and then mixed with 1000mL of normal saline. After carefully removing air bubble from the circuit with the prepared fluid, nafamostat mesilate was dissolved with 15 mL of 5% glucose fluid and loaded in anticoagulation line with starting dose of 20mg/hr.", 'armGroupLabels': ['HF1000', 'M100']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'collaborators': [{'name': 'SK Chemicals Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}