Correction Study of R744 in Renal Anemia Patients on Hemodialysis

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 determinedbefore 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 bloodpressure has been ≥ 100 mmHg on more than 1/3 of the determining occasions afterstarting of hemodialysis during the last week before registration)

• Patients with congestive cardiac failure (≥ Class III in NYHA cardiac functionclassification)

• Female patients who are pregnant, lactating, possibly pregnant or not willing to takea contraceptive measure during the period from the day of starting the treatment withthe 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 cerebralinfarction (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 ormepitiostane within 12 weeks before registration

• Patients who have received another investigational drug within 12 weeks beforeregistration

• Patients who have received R744 before registration

• Patients whose AST(GOT) value ≥ 100 IU/L or ALT(GPT) value ≥ 100 IU/L beforeregistration

• Patients who have received erythrocyte transfusion within 16 weeks before registration

• Patients for whom a surgical operation involved with heavy bleeding is planned duringthe study period

• In addition, patients who are judged as ineligible to participate in this study by theinvestigator or sub-investigator