Status:
COMPLETED
Clinical Study of R744 to Peritoneal Dialysis Patients
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Peritoneal Dialysis Patients
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Peritoneal Dialysis.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00433849
Start Date
February 1 2007
End Date
November 1 2008
Last Update
February 2 2009
Active Locations (6)
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1
Chugoku/Shikoku region
Chugoku/Shikoku, Japan
2
Chubu region
Chūbu, Japan
3
Hokkaido/Tohoku region
Hokkaido/Tohoku, Japan
4
Kanto/Koshinetsu region
Kanto/Koshinetsu, Japan