Clinical Study of R744 to Hemodialysis Patients
Phase 3
Completed
- Conditions
- Hemodialysis Patients
- Interventions
- Registration Number
- NCT00491868
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of intravenous injections of R744 in renal anemia patients on Hemodialysis patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
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
- Within 4 weeks before registration, patients who have been receiving a rHuEPO preparation 750IU (3 times a week), 1,500IU (twice a week (1st and 2nd hemodialysis day of the week, or1st and 3rd hemodialysis day of the week)), 1,500IU (3 times a week), or 3,000IU (twice a week (1st and 2nd hemodialysis day of the week, or1st and 3rd hemodialysis day of the week)), and patients who have not change dosage and administration.
- Patients whose pre-dialysis Hb concentrations has been between ≥ 9.0 g/dL and ≤12.0 g/dL and mean value of pre-dialysis Hb concentrations has been between ≥ 9.5 g/dL and ≤11.5 g/dL determined at the beginning of each week within 8 weeks before registration
- 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, testosterone propionate, methyltestosterone 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 3 R744 placebo - 1 R744 - 1 rHuEPO placebo - 2 R744 - 2 rHuEPO placebo - 4 R744 placebo - 3 rHuEPO - 4 rHuEPO -
- Primary Outcome Measures
Name Time Method Variation of Hb concentration from baseline Hb concentration in evaluation period week 17~24
- Secondary Outcome Measures
Name Time Method Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL and maintain Hb concentration in the range of ≥ 9.0g/dL and ≤ 12.0g/dL in evaluation period week 17~24 Rate of patients who maintain Hb concentration within ±1.0g/dL of reference Hb week 17~24 Adverse events throughout study Laboratory measurements throughout study Vital signs, standard 12-lead ECG throughout study Anti-R744 antibody titer throughout study Anti-Epoetin beta antibody titer throughout study
Trial Locations
- Locations (5)
Kyusyu region
🇯🇵Kyusyu, Japan
Chubu region
🇯🇵Chubu, Japan
Kanto/Koshinetsu region
🇯🇵Kanto/Koshinetsu, Japan
Chugoku/Shikoku region
🇯🇵Chugoku/Shikoku, Japan
Kinki/Hokuriku region
🇯🇵Kinki/Hokuriku, Japan