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

Kyowa Kirin Co., Ltd.200 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Anemia

Interventions

darbepoetin alfaDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (7)

Shikoku region

Ehime, Japan

Kyusyu region

Fukuoka, Kagoshima, Japan

Chugoku region

Hiroshima, Tottori, Japan

Tohoku region

Iwate, Miyagi, Japan

Outcomes

Primary Outcomes

To compare the proportion of subjects who reach red blood cell transfusion trigger

Secondary Outcomes

To compare the effectiveness of KRN321 on the proportion of subjects achieving hemoglobin response

To compare the proportion of subjects who receive red blood cell transfusions

To compare the effectiveness of KRN321 based on quality of life scores

Data from ClinicalTrials.gov

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