Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-29 @ 9:43 AM
Study NCT ID:
NCT00436995
Status:
COMPLETED
Last Update Posted:
2011-01-21
First Post:
2007-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'France', 'Germany', 'Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney 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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-20', 'studyFirstSubmitDate': '2007-02-15', 'studyFirstSubmitQcDate': '2007-02-15', 'lastUpdatePostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.', 'timeFrame': '33 weeks'}], 'secondaryOutcomes': [{'measure': 'Q2W doses over duration of study.', 'timeFrame': '33 weeks'}, {'measure': 'Hb values during the evaluation period.', 'timeFrame': '33 weeks'}, {'measure': 'adverse events during study', 'timeFrame': '33 weeks'}, {'measure': 'Hb Rate of Rise during study and excursions above 14g/dL', 'timeFrame': '33 weeks'}]}, 'conditionsModule': {'keywords': ['Dialysis', 'Anaemia'], 'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving dialysis for 3 months or more before enrollment.\n* The mean of 2 screening Hb values taken at least 7 days appart must be greater than or equal to 11g/dL and less than or equal to 13.0 g/dL\n* Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment\n* Adequate iron stores (serum ferritin equal to or greater than 100 ug/L\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Prior history of Cardiovascular Incidents 12 weeks prior to enrollment\n* Other hematological disorders\n* Upper or lower GI bleed within the prior 6 months'}, 'identificationModule': {'nctId': 'NCT00436995', 'briefTitle': 'Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Multicentre, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis.', 'orgStudyIdInfo': {'id': '20050210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single', 'interventionNames': ['Drug: Darbepoetin Alfa']}], 'interventions': [{'name': 'Darbepoetin Alfa', 'type': 'DRUG', 'description': 'Administered IV or SC, Q2W at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200 or 300ug. Initial Q2W dose calculated from pre-enrollment QW doses. Doses titrated to achieve target Hb.', 'armGroupLabels': ['Single']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Global Development Leader', 'oldOrganization': 'Amgen Inc.'}}}}