Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-26 @ 1:29 PM
Study NCT ID:
NCT00433693
Status:
COMPLETED
Last Update Posted:
2009-02-02
First Post:
2007-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correction Study of R744 in Renal Anemia Patients on Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C508420', 'term': 'continuous erythropoietin receptor activator'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-29', 'studyFirstSubmitDate': '2007-02-09', 'studyFirstSubmitQcDate': '2007-02-09', 'lastUpdatePostDateStruct': {'date': '2009-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The ratio of patients whose Hb concentration reach ≥ 10.0g/dL and increasing amount of Hb concentration reach ≥ 1.0g/dL', 'timeFrame': '26 weeks'}], 'secondaryOutcomes': [{'measure': 'Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration ≥ 1.0g/dL', 'timeFrame': '26 weeks'}, {'measure': 'Regression line of Hb concentration per week', 'timeFrame': '26 weeks'}, {'measure': 'Achievement rate of Hb concentration of ≥ 11.0 g/dL', 'timeFrame': '26 weeks'}, {'measure': 'Transition of Hb concentration', 'timeFrame': '26 weeks'}, {'measure': 'dose transition of study drug', 'timeFrame': '26 weeks'}, {'measure': 'Variation of QOL', 'timeFrame': '26 weeks'}, {'measure': 'Adverse events', 'timeFrame': '26 weeks'}, {'measure': 'Laboratory measurements', 'timeFrame': '26 weeks'}, {'measure': 'Vital signs, standard 12-lead ECG', 'timeFrame': '26 weeks'}, {'measure': 'Anti-R744 antibody titer', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemodialysis Patients']}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy and safety of intravenous R744 in renal anemia patients on hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been receiving hemodialysis more than 1 time a week\n* Patients aged ≥ 20 years at the time of obtaining consent\n* After starting of hemodialysis, patients who have not received rHuEPO preparation\n* After starting of hemodialysis, patients whose value of Hb concentrations determined before the first hemodialysis during the last week prior to the registration has been \\< 10.0 g/dL\n\nExclusion Criteria:\n\n* Patients with hardly controllable hypertension (patients whose diastolic blood pressure has been ≥ 100 mmHg on more than 1/3 of the determining occasions after starting of hemodialysis during the last week before registration)\n* Patients with congestive cardiac failure (≥ Class III in NYHA cardiac function classification)\n* Female patients who are pregnant, lactating, possibly pregnant or not willing to take a contraceptive measure during the period from the day of starting the treatment with the study drug to 90 days after the day of the last dose of the study drug\n* Patients with complication of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction)\n* Patients confirmed to have serious allergy or serious drug allergy (shock, anaphylactoid symptom)\n* Patients hypersensitive to a rHuEPO preparation\n* Patients with malignant tumor (including hemic malignant tumor), severe infection, systemic hemic disease (osteomyelodysplasia syndrome, hemoglobinopathy, etc.), hemolytic anemia or apparent hemorrhagic lesion such as digestive tract hemorrhage\n* Patients who have received an anabolic hormone preparation, testosterone enanthate or mepitiostane within 12 weeks before registration\n* Patients who have received another investigational drug within 12 weeks before registration\n* Patients who have received R744 before registration\n* Patients whose AST(GOT) value ≥ 100 IU/L or ALT(GPT) value ≥ 100 IU/L before registration\n* Patients who have received erythrocyte transfusion within 16 weeks before registration\n* Patients for whom a surgical operation involved with heavy bleeding is planned during the study period\n* In addition, patients who are judged as ineligible to participate in this study by the investigator or sub-investigator'}, 'identificationModule': {'nctId': 'NCT00433693', 'briefTitle': 'Correction Study of R744 in Renal Anemia Patients on Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chugai Pharmaceutical'}, 'officialTitle': 'Correction Study of Intravenous Injections of R744 to Hemodialysis Patients ( Phase Ⅲ Study ).', 'orgStudyIdInfo': {'id': 'JH20562'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: R744']}], 'interventions': [{'name': 'R744', 'type': 'DRUG', 'otherNames': ['methoxy polyethylene glycol-epoetin beta'], 'description': '50μg(i.v.)/2 week until Hb concentration reaches to 11.0g/dL or above, then 25\\~300μg(i.v.)/4 week', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku/Shikoku', 'country': 'Japan', 'facility': 'Chugoku/Shikoku region'}, {'city': 'Chūbu', 'country': 'Japan', 'facility': 'Chubu region', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokkaido/Tohoku', 'country': 'Japan', 'facility': 'Hokkaido/Tohoku region'}, {'city': 'Kanto/Koshinetsu', 'country': 'Japan', 'facility': 'Kanto/Koshinetsu region'}, {'city': 'Kinki/Hokuriku', 'country': 'Japan', 'facility': 'Kinki/Hokuriku region'}, {'city': 'Kyusyu', 'country': 'Japan', 'facility': 'Kyusyu region'}], 'overallOfficials': [{'name': 'Takanori Baba', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Research Department 2'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chugai Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chugai Pharmaceutical', 'oldOrganization': 'Chugai Pharmaceutical'}}}}