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

Primary Purpose

Anemia

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
darbepoetin alfa
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring darbepoetin alfa, anemia, cancer patients, chemotherapy

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tokai region
  • Shikoku region
  • Kyusyu region
  • Hokkaido region
  • Kinki region
  • Tohoku region
  • Hokuriku region
  • Kanto region

Outcomes

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

Full Information

First Posted
August 1, 2006
Last Updated
August 30, 2012
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00359840
Brief Title
A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
Official Title
A Randomized, Dose - Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
September 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 assess the clinical effective dose of KRN321 administered with once triweekly schedule.

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, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
darbepoetin alfa
Primary Outcome Measure Information:
Title
To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response
Secondary Outcome Measure Information:
Title
To compare the proportion of subjects who receive red blood cell transfusions or show the hemoglobin level below 8 g/dL
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 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
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
Tokai region
City
Aichi
Country
Japan
Facility Name
Shikoku region
City
Ehime
Country
Japan
Facility Name
Kyusyu region
City
Fukuoka, Kumamoto
Country
Japan
Facility Name
Hokkaido region
City
Hokkaido
Country
Japan
Facility Name
Kinki region
City
Kyoto, Osaka, Nara
Country
Japan
Facility Name
Tohoku region
City
Miyagi
Country
Japan
Facility Name
Hokuriku region
City
Niigata, Ishikawa
Country
Japan
Facility Name
Kanto region
City
Tochigi, Saitama, Tokyo, Kanagawa
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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