Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients (Phase Ⅲ Study)

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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Clinical Study of Switching From rHuEPO to R744 and Maintenance Treatment With R744 in Renal Anemia Patients on Hemodialysis (Phase Ⅲ Study)

Conditions
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Hemodialysis Patients

Intervention / Treatment
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* Drug: R744
* Drug: R744


Participation Criteria
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Eligibility Criteria
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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

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: R744<br>* 100μg/4 weeks for 8 weeks,then 25 400μg/4 weeks for 40 weeks<br>|
| Experimental: 2<br> | Drug: R744<br>* 150μg/4 weeks for 8 weeks,then 25 400μg/4 weeks for 40 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |