Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT01105494
Status:
COMPLETED
Last Update Posted:
2012-09-13
First Post:
2010-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of Epoetin Beta [Neorecormon] to Evaluate the Quality of Life in Patients on Dialysis With Chronic Renal Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C103998', 'term': 'epoetin beta'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-12', 'studyFirstSubmitDate': '2010-04-14', 'studyFirstSubmitQcDate': '2010-04-15', 'lastUpdatePostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life assessment: Kidney Disease Quality of Life Questionnaire', 'timeFrame': 'Throughout study: 6 months'}], 'secondaryOutcomes': [{'measure': 'Evaluation of factors (demographic and social characteristics, dialysis method) influencing the quality of life', 'timeFrame': 'Throughout study: 6 months'}]}, 'conditionsModule': {'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'This multicenter, prospective, observational study will evaluate the quality of life and the factors that influence the quality of life of epoetin beta \\[Neorecormon\\] in patients with renal chronic anemia, who are on dialysis. For each eligible patient data will be collected for 6 months. Target sample size is 5000-7000 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Dialysis patients with end-stage kidney disease on treatment with epoetin beta \\[Neorecormon\\]', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients \\>/=18 years of age\n* Dialysis patients with chronic renal anemia\n* Written informed consent\n\nExclusion Criteria:\n\n* Red blood cell transfusion in the previous 2 months\n* Severe neuropsychological disorder\n* Diabetic patients with serious complications\n\nThis trial is being conducted in Morocco.'}, 'identificationModule': {'nctId': 'NCT01105494', 'briefTitle': 'An Observational Study of Epoetin Beta [Neorecormon] to Evaluate the Quality of Life in Patients on Dialysis With Chronic Renal Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Prospective Study Evaluating the Quality of Life in Dialysis Patients With End Stage Renal Disease', 'orgStudyIdInfo': {'id': 'ML21906'}}, 'armsInterventionsModule': {'interventions': [{'name': 'epoetin beta [NeoRecormon]', 'type': 'DRUG', 'description': 'As prescribed by physician'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20000', 'city': 'Casablanca', 'country': 'Morocco', 'geoPoint': {'lat': 33.58831, 'lon': -7.61138}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}