Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-01-07 @ 1:32 PM
Study NCT ID:
NCT01879618
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2013-06-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use Of Fragmin In Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017985', 'term': 'Dalteparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From screening (-9 days) up to 30 days after last dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'FRAGMIN', 'description': 'Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.', 'otherNumAtRisk': 152, 'otherNumAffected': 27, 'seriousNumAtRisk': 152, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Arteriovenous fistula site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percent of Successful HD Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FRAGMIN', 'description': 'Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.9', 'groupId': 'OG000', 'lowerLimit': '99.7', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 HD sessions (up to 4 hours)', 'description': "A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.", 'unitOfMeasure': 'Percentage of HD Sessions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) was used for all efficacy analyses which included all participants who received at least one dose of study medication. There were 2776 HD sessions from 151 participants included in the primary analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Percent of HD Sessions With an Acceptable Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FRAGMIN', 'description': 'Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.8', 'groupId': 'OG000', 'lowerLimit': '87.4', 'upperLimit': '91.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 HD sessions (up to 4 hours)', 'description': 'A HD session with an acceptable dose is defined in terms of efficacy of the drug: an HD session for which the dose at the next HD session did not need to be changed due to Grade 3 or 4 clotting, bleeding, access compression time \\> 10 minutes, or other clinical event. The point estimate and 95% CI were computed based on GEE model for clustered binomial.', 'unitOfMeasure': 'Percentage of HD sessions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was used for all efficacy analyses which included all participants who received at least one dose of study medication. For this endpoint, there were 2630 evaluable HD sessions from 148 participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FRAGMIN', 'description': 'Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Does not meet entrance criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Surgery;changed schedule; not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'The study was conducted in 12 sites in Canada, 10 of which enrolled participants. A total of 152 participants with chronic renal failure, who had at least 30 previous days of hemodialysis (HD) and had received ≤10,000 IU unfractionated heparin or low molectular weight heparin for anticoagulation during the past month were enrolled in the study.', 'preAssignmentDetails': 'The Screening Visit was performed within 9 days preceding first HD session where FRAGMIN was administered. The Final Study Visit took place 5 to 15 days after the final study HD session where the participant was treated with Fragmin (# 20 or the last HD session that was completed, if the partcipant prematurely terminated).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'FRAGMIN', 'description': 'Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '14.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set consisted of all participants who received at least one dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2013-06-13', 'resultsFirstSubmitDate': '2016-11-02', 'studyFirstSubmitQcDate': '2013-06-13', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-02', 'studyFirstPostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent of Successful HD Sessions', 'timeFrame': '20 HD sessions (up to 4 hours)', 'description': "A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data."}], 'secondaryOutcomes': [{'measure': 'Mean Percent of HD Sessions With an Acceptable Dose', 'timeFrame': '20 HD sessions (up to 4 hours)', 'description': 'A HD session with an acceptable dose is defined in terms of efficacy of the drug: an HD session for which the dose at the next HD session did not need to be changed due to Grade 3 or 4 clotting, bleeding, access compression time \\> 10 minutes, or other clinical event. The point estimate and 95% CI were computed based on GEE model for clustered binomial.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fragmin', 'dalteparin', 'hemodialysis', 'anticoagulation', 'Renal Failure'], 'conditions': ['Chronic Renal Failure']}, 'referencesModule': {'references': [{'pmid': '30542622', 'type': 'DERIVED', 'citation': 'Soroka S, Agharazii M, Donnelly S, Roy L, Muirhead N, Cournoyer S, MacKinnon M, Pannu N, Barrett B, Madore F, Tennankore K, Wilson JA, Hilton F, Sherman N, Wolter K, Orazem J, Feugere G. An Adjustable Dalteparin Sodium Dose Regimen for the Prevention of Clotting in the Extracorporeal Circuit in Hemodialysis: A Clinical Trial of Safety and Efficacy (the PARROT Study). Can J Kidney Health Dis. 2018 Nov 4;5:2054358118809104. doi: 10.1177/2054358118809104. eCollection 2018.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6301091&StudyName=Use%20Of%20Fragmin%20In%20Hemodialysis', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic renal failure on hemodialysis\n\nExclusion Criteria:\n\n* significant comorbidities that would prevent a patient from completing the trial'}, 'identificationModule': {'nctId': 'NCT01879618', 'briefTitle': 'Use Of Fragmin In Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase IIIb Open Label Study To Optimize The Single Bolus Dose Of Dalteparin Sodium For The Prevention Of Clotting Within The Extracorporeal System During Hemodialysis Procedures For Subjects With Chronic Renal Insufficiency: The Parrot Study', 'orgStudyIdInfo': {'id': 'A6301091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fragmin', 'description': 'Fragmin given according to the flexible dosing regimen outlined in the protocol', 'interventionNames': ['Drug: Fragmin']}], 'interventions': [{'name': 'Fragmin', 'type': 'DRUG', 'description': 'variable dosing regimen', 'armGroupLabels': ['Fragmin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5G 0B8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6L 5X8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Grey Nuns Community Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Horizon Health Network/Saint John Regional Hospital', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Eastern Regional Health Authority, Health Sciences Centre', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'A1C 5B8', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': "Eastern Regional Health Authority, St. Clare's Mercy Hospital", 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'A1E 4J8', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Eastern Regional Health Authority, Waterford Hospital', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Sciences Center (QEII) - VG Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L6R 3J7', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'William Osler Health System - Bramptom Civic Hospital', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre, University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N6K 1M6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre, Kidney Care Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L9W 4X9', 'city': 'Orangeville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'William Osler Health System', 'geoPoint': {'lat': 43.9168, 'lon': -80.09967}}, {'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre intégré de santé et de services sociaux de la Montérégie-Centre', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'J4V 3M3', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre externe de néphrologie CISSS de la Montérégie-Centre', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H2X 3J4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Saint-Luc", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3M 3E3', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "CIUSSS du Nord-de-l'Ile-de-Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "CIUSSS du Nord-de-l'Ile-de-Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU de Quebec (Pavillon Hotel-Dieu de Quebec)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J4R 2L1', 'city': 'Saint-Lambert', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre externe de néphrologie CISSS de la Montérégie-Centre', 'geoPoint': {'lat': 45.50008, 'lon': -73.51028}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}