Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT00492427
Status:
COMPLETED
Last Update Posted:
2009-01-08
First Post:
2007-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C103998', 'term': 'epoetin beta'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-06', 'studyFirstSubmitDate': '2007-06-26', 'studyFirstSubmitQcDate': '2007-06-26', 'lastUpdatePostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients who maintain mean Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL', 'timeFrame': '26 weeks'}], 'secondaryOutcomes': [{'measure': 'Mean Hb concentration for term of evaluation', 'timeFrame': '26 weeks'}, {'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'}, {'measure': 'Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration of ≥ 1.0g/dL', 'timeFrame': '26 weeks'}, {'measure': 'Slope of regression line of Hb concentration per week', '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'}, {'measure': 'Anti-Epoetin beta antibody titer', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Predialysis Patients']}, 'referencesModule': {'references': [{'pmid': '36791280', 'type': 'DERIVED', 'citation': 'Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.'}]}, 'descriptionModule': {'briefSummary': 'This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of subcutaneous R744 in renal anemia patients on Predialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients whose serum creatinine level has been ≥ 2.0 mg/dL or creatinine clearance has been ≤ 30 mL /min at any one time point within 12 weeks before registration\n* Patients aged ≥ 20 years at the time of obtaining consent\n* Patients who have been not receiving a rHuEPO preparation at least 16 weeks before registration\n* Patients whose value of Hb concentrations determined the nearest week before registration has been \\< 10.0 g/dL\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 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': 'NCT00492427', 'briefTitle': 'Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chugai Pharmaceutical'}, 'officialTitle': 'Correction and Maintenance Study of Subcutaneous Injections of R744 to Predialysis Patients ( Phase III, Comparative Study in Comparison With Epoetin Beta)', 'orgStudyIdInfo': {'id': 'JH20565'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Epoetin beta']}, {'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: R744']}], 'interventions': [{'name': 'R744', 'type': 'DRUG', 'description': '25μg(s.c.)/2weeks until Hb concentration reaches to 10g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above, then 25\\~250μg(s.c.)/4week for 24\\~26weeks in total.', 'armGroupLabels': ['1']}, {'name': 'Epoetin beta', 'type': 'DRUG', 'description': '6000IU(s.c.)/week until Hb concentration reaches to 10.0g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above,then 3000k\\~12000IU(s.c.)/2week for 24\\~26weeks in total.', 'armGroupLabels': ['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': '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': 'Chugai Pharmaceutical,Clinical Research Department 2'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chugai Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Takanori Baba', 'oldOrganization': 'Chugai Pharmaceutical'}}}}