Overview
Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta)
Status:
Completed
Completed
Trial end date:
2008-11-01
2008-11-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Chugai PharmaceuticalTreatments:
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