A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor

Phase 2CompletedNCT00359840

Kyowa Kirin Co., Ltd.120 enrolled

Overview

To assess the clinical effective dose of KRN321 administered with once triweekly schedule.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Anemia

Interventions

darbepoetin alfaDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (8)

Tokai region

Aichi, Japan

Shikoku region

Ehime, Japan

Kyusyu region

Fukuoka, Kumamoto, Japan

Hokkaido region

Hokkaido, Japan

Outcomes

Primary Outcomes

To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response

Secondary Outcomes

To compare the proportion of subjects who receive red blood cell transfusions or show the hemoglobin level below 8 g/dL

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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