Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-03 @ 8:10 AM
Study NCT ID:
NCT02042833
Status:
COMPLETED
Last Update Posted:
2015-11-03
First Post:
2014-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of Patients' Perception of Treatment With Erythropoiesis-Stimulating Agents in Patients With Chronic Kidney Disease Not on Dialysis (PERCEPOLIS)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 815}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-02', 'studyFirstSubmitDate': '2014-01-21', 'studyFirstSubmitQcDate': '2014-01-21', 'lastUpdatePostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative importance for patients of different attributes of ESA treatment, assessed by Choice Based Conjoint questionnaire at baseline and Month 6', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Biological parameters: hemoglobin concentration at each observation time point.', 'timeFrame': '6 months'}, {'measure': 'Adherence to Mircera treatment assessed by a questionnaire adapted from the Morisky scale at baseline and at Month 6', 'timeFrame': '6 months'}, {'measure': 'Dose/schedule of Mircera treatment at each observation timepoint', 'timeFrame': '6 months'}, {'measure': 'Concomitant medication/treatments in the management of anemia', 'timeFrame': '6 months'}, {'measure': 'Proportion of patients with a hemoglobin level between 10 and 12 g/dL after 6 months of treatment with Mircera', 'timeFrame': 'Month 6'}, {'measure': 'Change in hemoglobin level', 'timeFrame': 'from baseline to Month 6'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': "This observational study will evaluate patients' perception of treatment with erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis. Eligible patients initiated on treatment with Mircera (methoxy polyethylene glycol-epoetin beta) will be followed for 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic kidney disease not on dialysis (with or without previous renal transplantation), initiating treatment with Mircera, and erythropoiesis-stimulating agent (ESA)-naïve or not', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Patients with chronic kidney disease not on dialysis (with or without previous renal transplantation)\n* Treated or not with ESA at time of visit\n* Patients for whom the treating physician had decided to initiate Mircera for medical reasons before the commencement of the study\n* Initiation of treatment with Mircera at the inclusion visit\n* Accepting and able of completing the ESA preference questionnaire\n\nExclusion Criteria:\n\n* Participation in a clinical trial on anemia\n* Treatment with Mircera during the 3 months before inclusion\n* Dialysis planned in the next 6 months'}, 'identificationModule': {'nctId': 'NCT02042833', 'briefTitle': "An Observational Study of Patients' Perception of Treatment With Erythropoiesis-Stimulating Agents in Patients With Chronic Kidney Disease Not on Dialysis (PERCEPOLIS)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'orgStudyIdInfo': {'id': 'ML25557'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Aix-en-Provence', 'country': 'France', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '20303', 'city': 'Ajaccio', 'country': 'France', 'geoPoint': {'lat': 41.91886, 'lon': 8.73812}}, {'zip': '07103', 'city': 'Annonay', 'country': 'France', 'geoPoint': {'lat': 45.23992, 'lon': 4.6707}}, {'zip': '62022', 'city': 'Arras', 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