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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00359840
First Posted: August 3, 2006
Last Update Posted: August 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
  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
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:


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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 1, 2006
First Posted: August 3, 2006
Last Update Posted: August 31, 2012
Last Verified: August 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