A Double-blind, Placebo Controlled, Randomized Study of KRN321 for the Treatment of Anemia in Cancer Patients
Phase 3
20 Years
74 Years
20 Years
74 Years
Not Enrolling
Both
Anemia
Both
Anemia
Trial Information
A Double-blind, Placebo Controlled, Randomized Study of KRN321 for the Treatment of Anemia in Cancer Patients
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
To compare the proportion of subjects who reach red blood cell transfusion trigger
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-A54
NCT ID:
NCT00344409
Start Date:
March 2006
Completion Date:
Related Keywords:
- Anemia
- darbepoetin alfa
- anemia
- cancer patients
- platinum containing chemotherapy
- Anemia
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