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

NCT ID: NCT00344409

Last Updated: 2012-08-31

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

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Brief Summary

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

Detailed Description

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Conditions

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Anemia

Keywords

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darbepoetin alfa anemia cancer patients platinum containing chemotherapy

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 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nagahiro Saijo, MD

Role: STUDY_CHAIR

National Cancer Center Hospital East

Locations

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Shikoku region

Ehime, , Japan

Site Status

Kyusyu region

Fukuoka, Kagoshima, , Japan

Site Status

Chugoku region

Hiroshima, Tottori, , Japan

Site Status

Tohoku region

Iwate, Miyagi, , Japan

Site Status

Kinki region

Nara, Osaka, Hyogo, , Japan

Site Status

Tokai region

Shizuoka, Aichi, , Japan

Site Status

Kanto region

Tokyo, Chiba, Ibaraki, Saitama, Niigata, , Japan

Site Status

Countries

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Japan

Other Identifiers

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KRN321-SC/05-A54

Identifier Type: -

Identifier Source: org_study_id