Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-02-04 @ 6:25 AM
Study NCT ID:
NCT02198495
Status:
COMPLETED
Last Update Posted:
2020-09-11
First Post:
2014-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2014-07-18', 'studyFirstSubmitQcDate': '2014-07-21', 'lastUpdatePostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum hemoglobin level (g/dl)', 'timeFrame': '40 weeks'}], 'secondaryOutcomes': [{'measure': 'Serum ferritin level (µg/l)', 'timeFrame': 'Week 0, 10, 20, 30, 40'}, {'measure': 'Serum transferrin level (mg/dl)', 'timeFrame': 'Week 0, 10, 20, 30, 40'}, {'measure': 'Serum level of transferrin saturation (TSAT) (%)', 'timeFrame': 'Week 0, 10, 20, 30, 40'}, {'measure': 'ESA consumption in I.E./week or µg/week as appropriate', 'timeFrame': 'Week 0, 10, 20, 30, 40'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anemia of Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '34470831', 'type': 'DERIVED', 'citation': 'Bielesz B, Lorenz M, Monteforte R, Prikoszovich T, Gabriel M, Wolzt M, Gleiss A, Horl WH, Sunder-Plassmann G. Comparison of Iron Dosing Strategies in Patients Undergoing Long-Term Hemodialysis: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2021 Oct;16(10):1512-1521. doi: 10.2215/CJN.03850321. Epub 2021 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'Patients with end-stage kidney disease on maintenance hemodialysis frequently require iron supplementation to compensate for ongoing iron losses, and to maintain hemoglobin levels with or without additional use of erythropoiesis-stimulating agents (ESA).\n\nThe investigators aim to compare two different intravenous iron preparations, ferric carboxymaltose and iron sucrose in 140 hemodialysis patients. The investigators primary objective is to assess whether both agents are equally effective to maintain a target haemoglobin within 10-12 mg/dl. The investigators will also measure ferritin, transferrin, transferrin saturation, and how much ESA therapy is administered.\n\nPatients will be randomly assigned to either treatment group and followed in parallel over an active study period of 40 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Male and female patients aged ≥ 18\n* Patients with anemia and end stage kidney disease on dialysis\n* Hemoglobin ≥ 8,5g/dl\n* Ferritin \\< 1000mg/dl\n* TSAT \\< 50%\n* CRP \\< 5mg/dl\n\nExclusion Criteria:\n\n* Hemoglobin \\< 8,5g/dl\n* Pregnancy or Nursing\n* Known allergic reaction to i.v. iron supplementation or to ingredients of Investigational Medicinal Product (IMP)\n* Chronic infections (HIV, Hep B, Hep C)\n* Acute infections (CRP\\>5mg/dl; Antibiotic therapy except for prophylactic use)\n* Malignant tumor disease\n* Oral iron supplementation at study inclusion\n* Participation in a different study at the same time\n* Active bleeding issues\n* Surgical intervention within the last 4 weeks before study inclusion\n* Mental diseases\n* Bronchial asthma\n* Atopic allergy\n* Eczema\n* Receipt of red blood cell (RBC) concentrate within the last 4 weeks before study inclusion'}, 'identificationModule': {'nctId': 'NCT02198495', 'acronym': 'COPEFER', 'briefTitle': 'Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Continuous Versus Periodic Intravenous Iron Supplementation in Maintenance Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'COPEFER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ferric carboxymaltose', 'description': 'Supplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30', 'interventionNames': ['Drug: Supplementation of ferric carboxymaltose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Iron sucrose', 'description': 'Supplementation of iron sucrose 100 mg at week 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38', 'interventionNames': ['Drug: Supplementation of iron sucrose']}], 'interventions': [{'name': 'Supplementation of ferric carboxymaltose', 'type': 'DRUG', 'armGroupLabels': ['Ferric carboxymaltose']}, {'name': 'Supplementation of iron sucrose', 'type': 'DRUG', 'armGroupLabels': ['Iron sucrose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna, Division of Nephrology and Dialysis', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1220', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Wiener Dialysezentrum GmbH', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Gere Sunder-Plassmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Gere Sunder-Plassmann', 'investigatorAffiliation': 'Medical University of Vienna'}}}}