A Randomized, Dose - Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
Phase 2
20 Years
74 Years
20 Years
74 Years
Not Enrolling
Both
Anemia
Both
Anemia
Trial Information
A Randomized, Dose - Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response
Principal Investigator
Nagahiro Saijo, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Center Hospital East
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
KRN321-SC/05-A55
NCT ID:
NCT00359840
Start Date:
July 2006
Completion Date:
Related Keywords:
- Anemia
- darbepoetin alfa
- anemia
- cancer patients
- chemotherapy
- Anemia
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