Back to resultsA Double-blind Study of KRN321 for the Treatment of Anemia in Cancer Patients
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
darbepoetin alfa
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring darbepoetin alfa, anemia, cancer patients, platinum containing chemotherapy
Eligibility 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
Sites / Locations
- Shikoku region
- Kyusyu region
- Chugoku region
- Tohoku region
- Kinki region
- Tokai region
- Kanto region
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00344409
Brief Title
A Double-blind Study of KRN321 for the Treatment of Anemia in Cancer Patients
Official Title
A Double-blind, Placebo Controlled, Randomized Study of KRN321 for the Treatment of Anemia in Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer patients receiving multi cycle platinum-containing chemotherapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
darbepoetin alfa, anemia, cancer patients, platinum containing chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
darbepoetin alfa
Primary Outcome Measure Information:
Title
To compare the proportion of subjects who reach red blood cell transfusion trigger
Secondary Outcome Measure Information:
Title
To compare the effectiveness of KRN321 on the proportion of subjects achieving hemoglobin response
Title
To compare the proportion of subjects who receive red blood cell transfusions
Title
To compare the effectiveness of KRN321 based on quality of life scores
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagahiro Saijo, MD
Organizational Affiliation
National Cancer Center Hospital East
Official's Role
Study Chair
Facility Information:
Facility Name
Shikoku region
City
Ehime
Country
Japan
Facility Name
Kyusyu region
City
Fukuoka, Kagoshima
Country
Japan
Facility Name
Chugoku region
City
Hiroshima, Tottori
Country
Japan
Facility Name
Tohoku region
City
Iwate, Miyagi
Country
Japan
Facility Name
Kinki region
City
Nara, Osaka, Hyogo
Country
Japan
Facility Name
Tokai region
City
Shizuoka, Aichi
Country
Japan
Facility Name
Kanto region
City
Tokyo, Chiba, Ibaraki, Saitama, Niigata
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Double-blind Study of KRN321 for the Treatment of Anemia in Cancer Patients
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