Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta)
- Registration Number
- NCT00492427
- Lead Sponsor
- Chugai Pharmaceutical
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 187
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 R744 - 2 Epoetin beta -
- Primary Outcome Measures
Name Time Method Rate of patients who maintain mean Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL 26 weeks
- Secondary Outcome Measures
Name Time Method Mean Hb concentration for term of evaluation 26 weeks The ratio of patients whose Hb concentration reach ≥ 10.0g/dL and increasing amount of Hb concentration reach ≥ 1.0g/dL 26 weeks Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration of ≥ 1.0g/dL 26 weeks Slope of regression line of Hb concentration per week 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 Anti-Epoetin beta antibody titer 26 weeks
Trial Locations
- Locations (6)
Kanto/Koshinetsu region
🇯🇵Kanto/Koshinetsu, Japan
Kyusyu region
🇯🇵Kyusyu, Japan
Kinki/Hokuriku region
🇯🇵Kinki/Hokuriku, Japan
Chugoku/Shikoku region
🇯🇵Chugoku/Shikoku, Japan
Chubu region
🇯🇵Chubu, Japan
Hokkaido/Tohoku region
🇯🇵Hokkaido/Tohoku, Japan