Anemia
Conditions
Keywords
darbepoetin alfa, anemia, cancer patients, chemotherapy
Brief summary
To assess the clinical effective dose of KRN321 administered with once triweekly schedule.
Interventions
DRUGdarbepoetin alfa
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Outcome results
None listed