Status:
COMPLETED
A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Anemia
Eligibility:
All Genders
20-74 years
Phase:
PHASE2
Brief Summary
To assess the clinical effective dose of KRN321 administered with once triweekly schedule.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00359840
Start Date
July 1 2006
Last Update
August 31 2012
Active Locations (8)
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1
Tokai region
Aichi, Japan
2
Shikoku region
Ehime, Japan
3
Kyusyu region
Fukuoka, Kumamoto, Japan
4
Hokkaido region
Hokkaido, Japan