A Double-blind Study of KRN321 for the Treatment of Anemia in Cancer Patients

Kyowa Kirin

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00344409

KRN321-SC/05-A54

Details and patient eligibility

About

To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer patients receiving multi cycle platinum-containing chemotherapy

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind