A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
NCT ID: NCT00359840
Last Updated: 2012-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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darbepoetin alfa
Eligibility Criteria
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Inclusion Criteria
* patients receiving cyclic chemotherapy
* written informed consent
* hemoglobin concentration below 11 d/dL at enrollment
* life expectancy of more than 4 months
Exclusion Criteria
* 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
20 Years
74 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Nagahiro Saijo, MD
Role: STUDY_CHAIR
National Cancer Center Hospital East
Locations
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Tokai region
Aichi, , Japan
Shikoku region
Ehime, , Japan
Kyusyu region
Fukuoka, Kumamoto, , Japan
Hokkaido region
Hokkaido, , Japan
Kinki region
Kyoto, Osaka, Nara, , Japan
Tohoku region
Miyagi, , Japan
Hokuriku region
Niigata, Ishikawa, , Japan
Kanto region
Tochigi, Saitama, Tokyo, Kanagawa, , Japan
Countries
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Other Identifiers
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KRN321-SC/05-A55
Identifier Type: -
Identifier Source: org_study_id