Anemia
Conditions
Keywords
darbepoetin alfa, anemia, cancer patients, platinum containing chemotherapy
Brief summary
To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer patients receiving multi cycle platinum-containing chemotherapy
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 lung or gynecological cancer * patients receiving platinum containing chemotherapy * written informed consent * hemoglobin concentration less than 11 d/dL at enrollment * life expectancy of more than 4 months
Exclusion criteria
* hemolysis, gastrointestinal bleeding, postoperative bleeding * iron deficiency * megaloblastic anemia * any primary hematological disorder that could cause anemia * received \> 2 RBC transfusions with 4 weeks or any RBC transfusion within 2 weeks before randomization * prior treatment with KRN321 * received erythropoetin therapy within 8 weeks before treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of subjects who reach red blood cell transfusion trigger | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effectiveness of KRN321 on the proportion of subjects achieving hemoglobin response | — |
| 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