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

Phase 3

Completed

• Conditions: Anemia

• Registration Number: NCT00344409
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-06-22
• Study First Submitted QC: 2006-06-22
• Study First Posted: 2006-06-26
• Primary Completion: 2007-05
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-30
• Last Update Posted: 2012-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To compare the effectiveness of KRN321 based on quality of life scores
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

Trial Locations

Locations (7)

Shikoku region; 🇯🇵 Ehime, Japan

Kyusyu region; 🇯🇵 Fukuoka, Kagoshima, Japan

Chugoku region; 🇯🇵 Hiroshima, Tottori, Japan

Tohoku region; 🇯🇵 Iwate, Miyagi, Japan

Kinki region; 🇯🇵 Nara, Osaka, Hyogo, Japan

Tokai region; 🇯🇵 Shizuoka, Aichi, Japan

Kanto region; 🇯🇵 Tokyo, Chiba, Ibaraki, Saitama, Niigata, Japan