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

Anemia Clinical Trial

Official title:

A Double-blind, Placebo Controlled, Randomized Study of KRN321 for the Treatment of Anemia in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344409
• Other study ID #: KRN321-SC/05-A54
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2006
• Last updated: August 30, 2012
• Start date: March 2006

Study information

• Verified date: August 2012
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• darbepoetin alfa

Locations

Country	Name	City	State
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the proportion of subjects who reach red blood cell transfusion trigger
Secondary	To compare the effectiveness of KRN321 on the proportion of subjects achieving hemoglobin response
Secondary	To compare the proportion of subjects who receive red blood cell transfusions
Secondary	To compare the effectiveness of KRN321 based on quality of life scores