Clinical Study of R744 to Peritoneal Dialysis Patients
- Registration Number
- NCT00433849
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Peritoneal Dialysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- Patients who have been receiving peritoneal dialysis 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 month for at least 8 weeks before registration
- Patients whose mean value of Hb concentrations determined within 8 weeks before registration has been between 10.0 g/dL and <12.0 g/dL
- Patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/mL at any one 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 had an onset of peritonitis within 4 weeks before registration
- 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 sub-investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 R744 - 2 R744 -
- Primary Outcome Measures
Name Time Method Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL 48 weeks
- Secondary Outcome Measures
Name Time Method Slope of regression line of Hb concentration (g/dL/week) 48 weeks Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL 48 weeks Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and < 13.0g/dL 48 weeks Laboratory measurements 48 weeks Adverse Event 48 weeks Anti-R744 antibody titer 48 weeks Vital signs, standard 12-lead ECG 48 weeks
Trial Locations
- Locations (6)
Kinki/Hokuriku region
🇯🇵Kinki/Hokuriku, Japan
Chubu region
🇯🇵Chubu, Japan
Chugoku/Shikoku region
🇯🇵Chugoku/Shikoku, Japan
Hokkaido/Tohoku region
🇯🇵Hokkaido/Tohoku, Japan
Kanto/Koshinetsu region
🇯🇵Kanto/Koshinetsu, Japan
Kyusyu region
🇯🇵Kyusyu, Japan