Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-25 @ 12:33 PM
Study NCT ID:
NCT01309295
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic 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': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-03-03', 'studyFirstSubmitQcDate': '2011-03-04', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines', 'timeFrame': '2 years'}, {'measure': 'Maintenance of target Hb range (10-12 g/dL)', 'timeFrame': '2 years'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Correlation between baseline clinical variables and time on target Hb level', 'timeFrame': '2 years'}, {'measure': 'Dosing pattern in clinical practice, including dose adaptations', 'timeFrame': '2 years'}, {'measure': 'Frequency of visits and laboratory assessments', 'timeFrame': '2 years'}, {'measure': 'Effect of compliance to treatment on Hb levels', 'timeFrame': '2 years'}]}, 'conditionsModule': {'conditions': ['Anemia, Kidney Disease, Chronic']}, 'descriptionModule': {'briefSummary': 'This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic kidney disease patients initiated on Mircera treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Chronic kidney disease, in pre-dialysis or dialysis\n* Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics\n\nExclusion Criteria:\n\n* Anemia due to non-renal causes\n* Pregnant or lactating women\n* Uncontrolled hypertension\n* Known hypersensitivity to methoxy polyethylene glycol-epoetin beta'}, 'identificationModule': {'nctId': 'NCT01309295', 'briefTitle': 'An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Prospective Study Evaluating the Efficacy and Safety of Mircera in Patients With CKD in Predialysis and Dialysis.', 'orgStudyIdInfo': {'id': 'ML25465'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Tirana', 'country': 'Albania', 'geoPoint': {'lat': 41.32744, 'lon': 19.81866}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}