Status:
COMPLETED
A Double-blind Study of KRN321 for the Treatment of Anemia in Cancer Patients
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Anemia
Eligibility:
All Genders
20-74 years
Phase:
PHASE3
Brief Summary
To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer patients receiving multi cycle platinum-containing chemotherapy
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00344409
Start Date
March 1 2006
Last Update
August 31 2012
Active Locations (7)
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1
Shikoku region
Ehime, Japan
2
Kyusyu region
Fukuoka, Kagoshima, Japan
3
Chugoku region
Hiroshima, Tottori, Japan
4
Tohoku region
Iwate, Miyagi, Japan