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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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darbepoetin alfa

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No