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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kyowa Hakko Kirin Co., Ltd

ClinicalTrials.gov Identifier:

NCT00359840

First received: August 1, 2006

Last updated: August 30, 2012

Last verified: August 2012

History of Changes

Purpose

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

Condition	Intervention	Phase
Anemia	Drug: darbepoetin alfa	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Drug Information available for: Darbepoetin Alfa

U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

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
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	20 Years to 74 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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, Japan

Sponsors and Collaborators

Kyowa Hakko Kirin Co., Ltd

Investigators


Study Chair:	Nagahiro Saijo, MD	National Cancer Center Hospital East

More Information


Responsible Party:	Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier:	NCT00359840 History of Changes
Other Study ID Numbers:	KRN321-SC/05-A55
Study First Received:	August 1, 2006
Last Updated:	August 30, 2012

Keywords provided by Kyowa Hakko Kirin Co., Ltd:


darbepoetin alfa anemia cancer patients chemotherapy

Additional relevant MeSH terms:


Anemia Hematologic Diseases Darbepoetin alfa Hematinics

ClinicalTrials.gov processed this record on June 27, 2017

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