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A Double-blind Study of KRN321 for the Treatment of Anemia in Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00344409
First Posted: June 26, 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 compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer patients receiving multi cycle platinum-containing chemotherapy

Condition Intervention Phase
Anemia Drug: darbepoetin alfa Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo Controlled, Randomized Study of KRN321 for the Treatment of Anemia in Cancer Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To compare the proportion of subjects who reach red blood cell transfusion trigger

Secondary Outcome Measures:
  • To compare the effectiveness of KRN321 on the proportion of subjects achieving hemoglobin response
  • 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: 200
Study Start Date: March 2006
Primary Completion Date: May 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 lung or gynecological cancer
  • patients receiving platinum containing chemotherapy
  • written informed consent
  • hemoglobin concentration less than 11 d/dL at enrollment
  • life expectancy of more than 4 months

Exclusion Criteria:

  • hemolysis, gastrointestinal bleeding, postoperative bleeding
  • iron deficiency
  • megaloblastic anemia
  • any primary hematological disorder that could cause anemia
  • received > 2 RBC transfusions with 4 weeks or any RBC transfusion within 2 weeks before randomization
  • 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): NCT00344409


Locations
Japan
Shikoku region
Ehime, Japan
Kyusyu region
Fukuoka, Kagoshima, Japan
Chugoku region
Hiroshima, Tottori, Japan
Tohoku region
Iwate, Miyagi, Japan
Kinki region
Nara, Osaka, Hyogo, Japan
Tokai region
Shizuoka, Aichi, Japan
Kanto region
Tokyo, Chiba, Ibaraki, Saitama, Niigata, 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: NCT00344409     History of Changes
Other Study ID Numbers: KRN321-SC/05-A54
First Submitted: June 22, 2006
First Posted: June 26, 2006
Last Update Posted: August 31, 2012
Last Verified: August 2012

Keywords provided by Kyowa Hakko Kirin Co., Ltd:
darbepoetin alfa
anemia
cancer patients
platinum containing chemotherapy

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics