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

This study has been completed.

First Received: August 1, 2006 Last Updated: March 12, 2009 History of Changes

Sponsor:	Kyowa Hakko Kirin Company, Limited
Information provided by:	Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:	NCT00359840

Purpose

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

Condition	Intervention	Phase
Anemia	Drug: darbepoetin alfa	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Dose - Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer

Drug Information available for: Darbepoetin alfa

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:

To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response

Secondary Outcome Measures:

To compare the proportion of subjects who receive red blood cell transfusions or show the hemoglobin level below 8 g/dL
To compare the proportion of subjects who receive red blood cell transfusions
To compare the effectiveness of KRN321 based on quality of life scores

Estimated Enrollment:	120
Study Start Date:	July 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359840

Locations

Japan
Hokkaido region
Hokkaido, Japan
Tohoku region
Miyagi, Japan
Kanto region
Tochigi, Saitama, Tokyo, Kanagawa, Japan
Hokuriku region
Niigata, Ishikawa, Japan
Kyusyu region
Fukuoka, Kumamoto, Japan
Kinki region
Kyoto, Osaka, Nara, Japan
Shikoku region
Ehime, Japan
Tokai region
Aichi, Japan

Sponsors and Collaborators

Kyowa Hakko Kirin Company, Limited

Investigators

Study Chair:

Nagahiro Saijo, MD

National Cancer Center Hospital East

More Information

No publications provided

Study ID Numbers:	KRN321-SC/05-A55
Study First Received:	August 1, 2006
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00359840 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:

darbepoetin alfa
anemia
cancer patients
chemotherapy

Additional relevant MeSH terms:

Hematinics
Hematologic Diseases
Therapeutic Uses
Hematologic Agents

Darbepoetin alfa
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010