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 Company, Limited
ClinicalTrials.gov Identifier:
NCT00359840
First received: August 1, 2006
Last updated: August 30, 2012
Last verified: August 2012
  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
Endpoint Classification: Safety/Efficacy Study
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:


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

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
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 Company, Limited
Investigators
Study Chair: Nagahiro Saijo, MD National Cancer Center Hospital East
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
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
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:
Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014