Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta)

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of subcutaneous R744 in renal anemia patients on Predialysis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chugai Pharmaceutical
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients whose serum creatinine level has been ≥ 2.0 mg/dL or creatinine clearance has been ≤ 30 mL /min at any one time point within 12 weeks before registration

• Patients aged ≥ 20 years at the time of obtaining consent

• Patients who have been not receiving a rHuEPO preparation at least 16 weeks before registration

• Patients whose value of Hb concentrations determined the nearest week before registration has been < 10.0 g/dL

• Patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/mL at any 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 16 weeks before registration

• Patients for whom a surgical operation accompanied by marked bleeding is planned during the study period

• In addition, patients who are judged as ineligible to participate in this study by the investigator or subinvestigator