NCT00433888CompletedPhase 3
Clinical Study of Switching From rHuEPO to R744 and Maintenance Treatment With R744 in Renal Anemia Patients on Hemodialysis (Phase Ⅲ Study)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Chugai Pharmaceutical
- Enrollment
- 179
- Locations
- 6
- Primary Endpoint
- Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL
Study Overview
Brief Summary
This study will assess the efficacy and safety of intravenous R744 in renal anemia patients on hemodialysis.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who have been receiving hemodialysis 3 times a week for at least 12 weeks before registration
- •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
- •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
- •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)
- •Patients with congestive cardiac failure (≥ Class III in NYHA cardiac function classification)
- •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
- •Patients with complication of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction)
- •Patients confirmed to have serious allergy or serious drug allergy (shock, anaphylactoid symptom)
- •Patients hypersensitive to a rHuEPO preparation
- •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
- •Patients who have received an anabolic hormone preparation, testosterone enanthate or mepitiostane within 12 weeks before registration
- •Patients who have received another investigational drug within 12 weeks before registration
- •Patients who have received R744 before registration
- •Patients whose AST(GOT) value ≥ 100 IU/L or ALT(GPT) value ≥ 100 IU/L before registration
- •Patients who have received erythrocyte transfusion within the last 16 weeks before registration
- •Patients for whom a surgical operation involved with heavy bleeding is planned during the study period
- •In addition, patients who are judged as ineligible to participate in this study by the investigator or sub-investigator
Arms & Interventions
1
Experimental
Intervention: R744 (Drug)
2
Experimental
Intervention: R744 (Drug)
Outcomes
Primary Outcomes
Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL
Time Frame: 48 weeks
Secondary Outcomes
- 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)
Investigators
Study Sites (6)
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