Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-03-14 @ 1:31 PM
Study NCT ID:
NCT00642967
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2008-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
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': 'C508420', 'term': 'continuous erythropoietin receptor activator'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-09', 'studyFirstSubmitDate': '2008-03-19', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period', 'timeFrame': 'Weeks 16-24'}], 'secondaryOutcomes': [{'measure': 'Mean change in Hb concentration', 'timeFrame': 'Between reference and Efficacy Evaluation Period'}, {'measure': 'Mean time spent in Hb range', 'timeFrame': 'Weeks 16-24'}, {'measure': '% patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions', 'timeFrame': 'Weeks 16-48'}, {'measure': 'AEs, lab parameters', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis;\n* continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month.\n\nExclusion Criteria:\n\n* transfusion of red blood cells during previous 2 months;\n* significant acute or chronic bleeding;\n* poorly controlled hypertension.'}, 'identificationModule': {'nctId': 'NCT00642967', 'briefTitle': 'A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Single Arm, Open Label, French Multi-centre Study to Assess the Maintenance of Hemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease Not on Dialysis', 'orgStudyIdInfo': {'id': 'ML21146'}, 'secondaryIdInfos': [{'id': '2007-005757-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methoxy Polyethylene Glycol-epoetin Beta', 'description': 'Participants will receive subcutaneous methoxy polyethylene glycol-epoetin beta every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.', 'interventionNames': ['Drug: Methoxy Polyethylene Glycol-epoetin Beta']}], 'interventions': [{'name': 'Methoxy Polyethylene Glycol-epoetin Beta', 'type': 'DRUG', 'otherNames': ['Mircera', 'C.E.R.A'], 'description': 'Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 mcg will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.', 'armGroupLabels': ['Methoxy Polyethylene Glycol-epoetin Beta']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13090', 'city': 'Aix-en-Provence', 'country': 'France', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '07103', 'city': 'Annonay', 'country': 'France', 'geoPoint': {'lat': 45.23992, 'lon': 4.6707}}, {'zip': '84902', 'city': 'Avignon', 'country': 'France', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '20604', 'city': 'Bastia', 'country': 'France', 'geoPoint': {'lat': 42.70219, 'lon': 9.45123}}, {'zip': '60000', 'city': 'Beauvais', 'country': 'France', 'geoPoint': {'lat': 49.43333, 'lon': 2.08333}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '76233', 'city': 'Bois-Guillaume', 'country': 'France', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'zip': '33077', 'city': 'Bordeaux', 'country': 'France', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '62321', 'city': 'Boulogne-sur-Mer', 'country': 'France', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'zip': '01012', 'city': 'Bourg-en-Bresse', 'country': 'France', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'zip': '18020', 'city': 'Bourges', 'country': 'France', 'geoPoint': {'lat': 47.08333, 'lon': 2.4}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '71100', 'city': 'Chalon-sur-Saône', 'country': 'France', 'geoPoint': {'lat': 46.78112, 'lon': 4.85372}}, {'zip': '28000', 'city': 'Chartres', 'country': 'France', 'geoPoint': {'lat': 48.44685, 'lon': 1.48925}}, {'zip': '50102', 'city': 'Cherbourg Octeville', 'country': 'France'}, {'zip': '49300', 'city': 'Cholet', 'country': 'France', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'zip': '63058', 'city': 'Clermont-Ferrand', 'country': 'France', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '68024', 'city': 'Colmar', 'country': 'France', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '60100', 'city': 'Creil', 'country': 'France', 'geoPoint': {'lat': 49.25672, 'lon': 2.48477}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '76202', 'city': 'Dieppe', 'country': 'France', 'geoPoint': {'lat': 49.9216, 'lon': 1.07772}}, {'zip': '27023', 'city': 'Évreux', 'country': 'France', 'geoPoint': {'lat': 49.02414, 'lon': 1.15082}}, {'zip': '69400', 'city': 'Greize', 'country': 'France'}, {'zip': '76700', 'city': 'Harfleur', 'country': 'France', 'geoPoint': {'lat': 49.5066, 'lon': 0.19827}}, {'zip': '92250', 'city': 'La Garenne-Colombes', 'country': 'France', 'geoPoint': {'lat': 48.90472, 'lon': 2.2469}}, {'zip': '38701', 'city': 'La Tronche', 'country': 'France', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '76083', 'city': 'Le Havre', 'country': 'France', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}, {'zip': '72037', 'city': 'Le Mans', 'country': 'France', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '59042', 'city': 'Lille', 'country': 'France', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '59604', 'city': 'Maubeuge', 'country': 'France', 'geoPoint': {'lat': 50.27875, 'lon': 3.97267}}, {'zip': '57045', 'city': 'Metz', 'country': 'France', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '74370', 'city': 'Metz-Tessy', 'country': 'France', 'geoPoint': {'lat': 45.93343, 'lon': 6.10973}}, {'zip': '03108', 'city': 'Montluçon', 'country': 'France', 'geoPoint': {'lat': 46.34015, 'lon': 2.60254}}, {'zip': '34097', 'city': 'Montpellier', 'country': 'France', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54100', 'city': 'Nancy', 'country': 'France', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '06002', 'city': 'Nice', 'country': 'France', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30006', 'city': 'Nîmes', 'country': 'France', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '45000', 'city': 'Orléans', 'country': 'France', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75743', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75908', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '29000', 'city': 'Quimper', 'country': 'France', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '59056', 'city': 'Roubaix', 'country': 'France', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'zip': '22027', 'city': 'Saint-Brieuc', 'country': 'France', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'zip': '06721', 'city': 'Saint-Laurent-du-Var', 'country': 'France', 'geoPoint': {'lat': 43.67323, 'lon': 7.19}}, {'zip': '50009', 'city': 'Saint-Lô', 'country': 'France', 'geoPoint': {'lat': 49.11624, 'lon': -1.09031}}, {'zip': '16470', 'city': 'Saint-Michel', 'country': 'France', 'geoPoint': {'lat': 49.91952, 'lon': 4.13278}}, {'zip': '44606', 'city': 'Saint-Nazaire', 'country': 'France', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'zip': '80480', 'city': 'Salouël', 'country': 'France', 'geoPoint': {'lat': 49.86988, 'lon': 2.2434}}, {'zip': '89108', 'city': 'Sens', 'country': 'France', 'geoPoint': {'lat': 48.19738, 'lon': 3.28328}}, {'zip': '35043', 'city': 'St-Malo', 'country': 'France', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '92151', 'city': 'Suresnes', 'country': 'France', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '57126', 'city': 'Thionville', 'country': 'France', 'geoPoint': {'lat': 49.35994, 'lon': 6.16044}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '77220', 'city': 'Tournan-en-Brie', 'country': 'France', 'geoPoint': {'lat': 48.74146, 'lon': 2.772}}, {'zip': '59300', 'city': 'Valenciennes', 'country': 'France', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '56017', 'city': 'Vannes', 'country': 'France', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}