A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
Phase 2
Completed
- Conditions
- Anemia
- Registration Number
- NCT00359840
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
To assess the clinical effective dose of KRN321 administered with once triweekly schedule.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- patients diagnosed as solid tumor or malignant lymphoma
- patients receiving cyclic chemotherapy
- written informed consent
- hemoglobin concentration below 11 d/dL at enrollment
- life expectancy of more than 4 months
Exclusion Criteria
- hemolysis, gastrointestinal bleeding, postoperative bleeding
- iron deficiency
- megaloblastic anemia
- received > 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization
- any primary hematological disorder that could cause anemia
- prior treatment with KRN321
- received erythropoetin therapy within 8 weeks before treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response
- Secondary Outcome Measures
Name Time Method To compare the proportion of subjects who receive red blood cell transfusions or show the hemoglobin level below 8 g/dL To compare the proportion of subjects who receive red blood cell transfusions To compare the effectiveness of KRN321 based on quality of life scores
Trial Locations
- Locations (8)
Tokai region
🇯🇵Aichi, Japan
Kanto region
🇯🇵Tochigi, Saitama, Tokyo, Kanagawa, Japan
Hokuriku region
🇯🇵Niigata, Ishikawa, Japan
Shikoku region
🇯🇵Ehime, Japan
Hokkaido region
🇯🇵Hokkaido, Japan
Kyusyu region
🇯🇵Fukuoka, Kumamoto, Japan
Tohoku region
🇯🇵Miyagi, Japan
Kinki region
🇯🇵Kyoto, Osaka, Nara, Japan