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

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

Tracking Information

• First Submitted Date: August 1, 2006
• First Posted Date: August 3, 2006
• Last Update Posted Date: August 31, 2012
• Study Start Date: July 2006
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 1, 2006): To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief Summary: To assess the clinical effective dose of KRN321 administered with once triweekly schedule.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Anemia
• Intervention: Drug: darbepoetin alfa
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: August 1, 2006): 120
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 74 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00359840
• Other Study ID Numbers: KRN321-SC/05-A55
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kyowa Kirin Co., Ltd.
• Study Sponsor: Kyowa Kirin Co., Ltd.
• Collaborators: Not Provided

Investigators

• Study Chair: Nagahiro Saijo, MD; National Cancer Center Hospital East

• PRS Account: Kyowa Kirin Co., Ltd.
• Verification Date: August 2012