Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-01 @ 9:58 AM
Study NCT ID:
NCT03146793
Status:
UNKNOWN
Last Update Posted:
2017-05-10
First Post:
2017-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Early Administration of Sodium Thiosulfate Should Help to Reduce the Mortality of Dialysis Patients With Calciphylaxis, From a National Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002115', 'term': 'Calciphylaxis'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C017717', 'term': 'sodium thiosulfate'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-08', 'studyFirstSubmitDate': '2017-05-08', 'studyFirstSubmitQcDate': '2017-05-08', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'time factor on mortality', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Calciphylaxis/complications', 'Kidney Failure, Chronic/complications', 'Renal Dialysis', 'Thiosulfates/therapeutic use', 'Time Factors'], 'conditions': ['Calciphylaxis', 'Renal Insufficiency, Chronic']}, 'referencesModule': {'references': [{'pmid': '17141359', 'type': 'BACKGROUND', 'citation': 'Weenig RH, Sewell LD, Davis MD, McCarthy JT, Pittelkow MR. Calciphylaxis: natural history, risk factor analysis, and outcome. J Am Acad Dermatol. 2007 Apr;56(4):569-79. doi: 10.1016/j.jaad.2006.08.065. Epub 2006 Dec 1.'}, {'pmid': '26253008', 'type': 'BACKGROUND', 'citation': 'Perceau G. [Uraemic and non-uraemic calcific arteriopathy: The need for rapid diagnosis and therapy]. Ann Dermatol Venereol. 2015 Aug-Sep;142(8-9):506-12. doi: 10.1016/j.annder.2015.06.009. Epub 2015 Aug 5. French.'}, {'pmid': '23520041', 'type': 'BACKGROUND', 'citation': 'Nigwekar SU, Brunelli SM, Meade D, Wang W, Hymes J, Lacson E Jr. Sodium thiosulfate therapy for calcific uremic arteriolopathy. Clin J Am Soc Nephrol. 2013 Jul;8(7):1162-70. doi: 10.2215/CJN.09880912. Epub 2013 Mar 21.'}, {'pmid': '26908770', 'type': 'BACKGROUND', 'citation': 'Brandenburg VM, Kramann R, Rothe H, Kaesler N, Korbiel J, Specht P, Schmitz S, Kruger T, Floege J, Ketteler M. Calcific uraemic arteriolopathy (calciphylaxis): data from a large nationwide registry. Nephrol Dial Transplant. 2017 Jan 1;32(1):126-132. doi: 10.1093/ndt/gfv438.'}, {'pmid': '21176746', 'type': 'BACKGROUND', 'citation': 'Sood AR, Wazny LD, Raymond CB, Leung K, Komenda P, Reslerova M, Verrelli M, Rigatto C, Sood MM. Sodium thiosulfate-based treatment in calcific uremic arteriolopathy: a consecutive case series. Clin Nephrol. 2011 Jan;75(1):8-15.'}]}, 'descriptionModule': {'briefSummary': 'The national drug safety agency authorizes nominatively the use of sodium thiosulfate in dialysis patients with calciphylaxis. To date, it is the largest global cohort (more 600 patients from 2012 to 2016). We wanted to study retrospectively the fate of these patients at 6 months including mortality. Early use improves effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Dialysis patients with calciphylaxis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All dialysis patients with calciphylaxis in France who have obtained a temporary use authorization for sodium thiosulfate by National Agency for the Safety of Medicines\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT03146793', 'briefTitle': 'The Early Administration of Sodium Thiosulfate Should Help to Reduce the Mortality of Dialysis Patients With Calciphylaxis, From a National Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier St Esprit'}, 'officialTitle': 'National Follow-up of Dialysis Patients With Sodium Thiosufate-treated Calciphylaxis Under Temporary Use Authorization', 'orgStudyIdInfo': {'id': 'Centre Hospitalier St Esprit'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sodium Thiosulfate', 'type': 'DRUG', 'description': '25g intravenously 3 times per week'}]}, 'contactsLocationsModule': {'locations': [{'zip': '47000', 'city': 'Agen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Albert TRINH-DUC, MD', 'role': 'CONTACT', 'email': 'albert.trinh-duc@wanadoo.fr', 'phone': '0033675743871'}, {'name': 'Isabelle MOUSNIER, MD', 'role': 'CONTACT', 'email': 'dr_eaza@yahoo.fr', 'phone': '0033660190002'}, {'name': 'David LARMET BURGEOT, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier St ESPRIT', 'geoPoint': {'lat': 44.20199, 'lon': 0.62055}}], 'centralContacts': [{'name': 'Albert TRINH-DUC, MD', 'role': 'CONTACT', 'email': 'albert.trinh-duc@wanadoo.fr', 'phone': '0033675743871'}, {'name': 'Isabelle MOUSNIER, MD', 'role': 'CONTACT', 'email': 'dr_eaza@yahoo.fr', 'phone': '0033660190002'}], 'overallOfficials': [{'name': 'Albert TRINH-DUC, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier St EPSRIT AGEN FRANCE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier St Esprit', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Albert TRINH-DUC', 'investigatorAffiliation': 'Centre Hospitalier St Esprit'}}}}