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

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.
 
ClinicalTrials.gov Identifier: NCT00359840
Recruitment Status : Completed
First Posted : August 3, 2006
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 1, 2006
First Posted Date  ICMJE August 3, 2006
Last Update Posted Date August 31, 2012
Study Start Date  ICMJE July 2006
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2006)
To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
Official Title  ICMJE A Randomized, Dose - Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
Brief Summary To assess the clinical effective dose of KRN321 administered with once triweekly schedule.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Anemia
Intervention  ICMJE Drug: darbepoetin alfa
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 1, 2006)
120
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00359840
Other Study ID Numbers  ICMJE KRN321-SC/05-A55
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyowa Kirin Co., Ltd.
Study Sponsor  ICMJE Kyowa Kirin Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Nagahiro Saijo, MD National Cancer Center Hospital East
PRS Account Kyowa Kirin Co., Ltd.
Verification Date August 2012

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