A Dose Finding Study of KRN321(Darbepoetin Alfa) for the... | NCT00359840

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

NCT00359840

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Aug 31, 2012Estimated

Enrollment

120Estimated

Phase

Phase 2

Conditions

Anemia

Interventions

darbepoetin alfa

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Sep 2007Actual

Completion Date

Not provided

First Submitted Date

Aug 1, 2006

First Submission Date that Met QC Criteria

Aug 1, 2006

First Posted Date

Aug 3, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2012

Last Update Posted Date

Aug 31, 2012Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Name	Type	Description	Arm Group Labels	Other Names
darbepoetin alfa	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nagahiro Saijo, MD	National Cancer Center Hospital East	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tokai region		Aichi			Japan
Shikoku region

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068256	Darbepoetin alfa

Ancestor Terms

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates

Browse Leaves

Not provided

Browse Branches

Not provided