Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-24 @ 10:34 PM
Study NCT ID:
NCT00491868
Status:
COMPLETED
Last Update Posted:
2009-02-02
First Post:
2007-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of R744 to Hemodialysis Patients
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-29', 'studyFirstSubmitDate': '2007-06-25', 'studyFirstSubmitQcDate': '2007-06-25', 'lastUpdatePostDateStruct': {'date': '2009-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of Hb concentration from baseline Hb concentration in evaluation period', 'timeFrame': 'week 17~24'}], 'secondaryOutcomes': [{'measure': 'Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL and maintain Hb concentration in the range of ≥ 9.0g/dL and ≤ 12.0g/dL in evaluation period', 'timeFrame': 'week 17~24'}, {'measure': 'Rate of patients who maintain Hb concentration within ±1.0g/dL of reference Hb', 'timeFrame': 'week 17~24'}, {'measure': 'Adverse events', 'timeFrame': 'throughout study'}, {'measure': 'Laboratory measurements', 'timeFrame': 'throughout study'}, {'measure': 'Vital signs, standard 12-lead ECG', 'timeFrame': 'throughout study'}, {'measure': 'Anti-R744 antibody titer', 'timeFrame': 'throughout study'}, {'measure': 'Anti-Epoetin beta antibody titer', 'timeFrame': 'throughout study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hemodialysis Patients']}, 'descriptionModule': {'briefSummary': 'This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of intravenous injections of R744 in renal anemia patients on Hemodialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been receiving hemodialysis 3 times a week for at least 12 weeks before registration\n* Patients aged ≥ 20 years at the time of obtaining consent\n* Patients who have been receiving a rHuEPO preparation at least once a week for at least 8 weeks before registration\n* Within 4 weeks before registration, patients who have been receiving a rHuEPO preparation 750IU (3 times a week), 1,500IU (twice a week (1st and 2nd hemodialysis day of the week, or1st and 3rd hemodialysis day of the week)), 1,500IU (3 times a week), or 3,000IU (twice a week (1st and 2nd hemodialysis day of the week, or1st and 3rd hemodialysis day of the week)), and patients who have not change dosage and administration.\n* Patients whose pre-dialysis Hb concentrations has been between ≥ 9.0 g/dL and ≤12.0 g/dL and mean value of pre-dialysis Hb concentrations has been between ≥ 9.5 g/dL and ≤11.5 g/dL determined at the beginning of each week within 8 weeks before registration\n* Patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/mL at any time point within 8 weeks before registration\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 within 12 weeks 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 in 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, testosterone propionate, methyltestosterone 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 accompanied by marked 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 subinvestigator'}, 'identificationModule': {'nctId': 'NCT00491868', 'briefTitle': 'Clinical Study of R744 to Hemodialysis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chugai Pharmaceutical'}, 'officialTitle': 'Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients ( Phase III, Double Blind Study in Comparison With Epoetin Beta).', 'orgStudyIdInfo': {'id': 'JH20876'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: R744', 'Drug: rHuEPO placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: R744', 'Drug: rHuEPO placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: rHuEPO', 'Drug: R744 placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: rHuEPO', 'Drug: R744 placebo']}], 'interventions': [{'name': 'R744', 'type': 'DRUG', 'otherNames': ['methoxy polyethylene glycol-epoetin beta'], 'description': '100μg/4week for 8 weeks, then 50\\~250μg/4week for 16 weeks', 'armGroupLabels': ['1']}, {'name': 'R744', 'type': 'DRUG', 'otherNames': ['methoxy polyethylene glycol-epoetin beta'], 'description': '150μg/4week for 8 weeks, then 50\\~250μg/4week for 16 weeks', 'armGroupLabels': ['2']}, {'name': 'rHuEPO', 'type': 'DRUG', 'description': '2250IU or 3000IU(i.v.) 2 or 3 times/week for 8 weeks, then 750\\~9000IU(i.v.)/1\\~3week for 16 weeks', 'armGroupLabels': ['3']}, {'name': 'rHuEPO', 'type': 'DRUG', 'description': '4500IU or 6000IU(i.v.) 2 or 3times/week for 8 weeks, then 750\\~9000IU(i.v.)/1\\~3week for 16 weeks', 'armGroupLabels': ['4']}, {'name': 'R744 placebo', 'type': 'DRUG', 'description': '0 μg/4week for 24 weeks', 'armGroupLabels': ['3', '4']}, {'name': 'rHuEPO placebo', 'type': 'DRUG', 'description': '0 IU 2 or 3 times/week for 8 weeks, then 1\\~3 times/week for 16 weeks', 'armGroupLabels': ['1', '2']}]}, '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': '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': 'Chugai Pharmaceutical,Clinical Research Department 2'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chugai Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chugai Pharmaceutical', 'oldOrganization': 'Chugai Pharmaceutical'}}}}