Correction Study of R744 in Renal Anemia Patients on Hemodialysis

Study Overview
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Brief Summary
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This study will assess the efficacy and safety of intravenous R744 in renal anemia patients on hemodialysis.

Official Title
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Correction Study of Intravenous Injections of R744 to Hemodialysis Patients ( Phase Ⅲ Study ).

Conditions
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Hemodialysis Patients

Intervention / Treatment
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* Drug: R744


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have been receiving hemodialysis more than 1 time a week Patients aged ≥ 20 years at the time of obtaining consent After starting of hemodialysis, patients who have not received rHuEPO preparation 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 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 after starting of hemodialysis during the last week 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 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 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 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: R744<br>* 50μg(i.v.)/2 week until Hb concentration reaches to 11.0g/dL or above, then 25 300μg(i.v.)/4 week<br>* Other names: methoxy polyethylene glycol-epoetin beta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of patients whose Hb concentration reach ≥ 10.0g/dL and increasing amount of Hb concentration reach ≥ 1.0g/dL |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration ≥ 1.0g/dL |  | 26 weeks | 
| Regression line of Hb concentration per week |  | 26 weeks | 
| Achievement rate of Hb concentration of ≥ 11.0 g/dL |  | 26 weeks | 
| Transition of Hb concentration |  | 26 weeks | 
| dose transition of study drug |  | 26 weeks | 
| Variation of QOL |  | 26 weeks | 
| Adverse events |  | 26 weeks | 
| Laboratory measurements |  | 26 weeks | 
| Vital signs, standard 12-lead ECG |  | 26 weeks | 
| Anti-R744 antibody titer |  | 26 weeks |