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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.
• Treatments: Darbepoetin alfa

Criteria

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