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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359840
• Other study ID #: KRN321-SC/05-A55
• Status: Completed
• Phase: Phase 2
• First received: August 1, 2006
• Last updated: August 30, 2012
• Start date: July 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 assess the clinical effective dose of KRN321 administered with once triweekly schedule.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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	Tokai region	Aichi
Japan	Shikoku region	Ehime
Japan	Kyusyu region	Fukuoka, Kumamoto
Japan	Hokkaido region	Hokkaido
Japan	Kinki region	Kyoto, Osaka, Nara
Japan	Tohoku region	Miyagi
Japan	Hokuriku region	Niigata, Ishikawa
Japan	Kanto region	Tochigi, Saitama, Tokyo, Kanagawa

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 effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response
Secondary	To compare the proportion of subjects who receive red blood cell transfusions or show the hemoglobin level below 8 g/dL
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