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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
June 22, 2006
June 26, 2006
August 31, 2012
March 2006
May 2007   (Final data collection date for primary outcome measure)
To compare the proportion of subjects who reach red blood cell transfusion trigger
Same as current
Complete list of historical versions of study NCT00344409 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Double-blind Study of KRN321 for the Treatment of Anemia in Cancer Patients
A Double-blind, Placebo Controlled, Randomized Study of KRN321 for the Treatment of Anemia in Cancer Patients
To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer patients receiving multi cycle platinum-containing chemotherapy
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Anemia
Drug: darbepoetin alfa
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
Not Provided
May 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00344409
KRN321-SC/05-A54
Not Provided
Not Provided
Not Provided
Kyowa Hakko Kirin Co., Ltd
Kyowa Hakko Kirin Co., Ltd
Not Provided
Study Chair: Nagahiro Saijo, MD National Cancer Center Hospital East
Kyowa Hakko Kirin Co., Ltd
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP