Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients (Phase Ⅲ Study)
Study Details
Study Description
Brief Summary
This study will assess the efficacy and safety of intravenous R744 in renal anemia patients on hemodialysis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1
|
Drug: R744
100μg/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks
|
Experimental: 2
|
Drug: R744
150μg/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks
|
Outcome Measures
Primary Outcome Measures
- Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL [48 weeks]
Secondary Outcome Measures
- Slope of regression line of Hb concentration (g/dL/week) [48 weeks]
- Rate of patients who maintain Hb concentration in the range of baseline* ± 1.0g/dL [48 weeks]
- Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and < 13.0g/dL [48 weeks]
- Adverse events [48 weeks]
- Laboratory measurements [48 weeks]
- Vital signs, standard 12-lead ECG [48 weeks]
- Anti-R744 antibody titer [48 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who have been receiving hemodialysis 3 times a week for at least 12 weeks before registration
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Patients aged ≥ 20 years at the time of obtaining consent Patients who have been receiving a rHuEPO preparation at least once a week for at least 8 weeks before registration
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Patients whose mean value of Hb concentrations determined before the first dialysis of each week within 8 weeks prior to the registration has been between ≥ 10.0 g/dL and <12.0 g/dL
-
Patients whose transferrin saturation has been ≥ 20 % or ferritin has been
-
100ng/mL at any one time point within 8 weeks before registration
Exclusion Criteria:
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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)
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Patients with congestive cardiac failure (≥ Class III in NYHA cardiac function classification)
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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
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Patients with complication of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction)
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Patients confirmed to have serious allergy or serious drug allergy (shock, anaphylactoid symptom)
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Patients hypersensitive to a rHuEPO preparation
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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
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Patients who have received an anabolic hormone preparation, testosterone enanthate or mepitiostane within 12 weeks before registration
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Patients who have received another investigational drug within 12 weeks before registration
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Patients who have received R744 before registration
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Patients whose AST(GOT) value ≥ 100 IU/L or ALT(GPT) value ≥ 100 IU/L before registration
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Patients who have received erythrocyte transfusion within the last 16 weeks before registration
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Patients for whom a surgical operation involved with heavy bleeding is planned during the study period
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In addition, patients who are judged as ineligible to participate in this study by the investigator or sub-investigator
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Chubu region | Chubu | Japan | ||
2 | Chugoku/Shikoku region | Chugoku/Shikoku | Japan | ||
3 | Hokkaido/Tohoku region | Hokkaido/Tohoku | Japan | ||
4 | Kanto/Koshinetsu region | Kanto/Koshinetsu | Japan | ||
5 | Kinki/Hokuriku region | Kinki/Hokuriku | Japan | ||
6 | Kyusyu region | Kyusyu | Japan |
Sponsors and Collaborators
- Chugai Pharmaceutical
Investigators
- Study Chair: Takanori Baba, Clinical Research Department 2
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JH20563