NCT00359840

Brief Summary

To assess the clinical effective dose of KRN321 administered with once triweekly schedule.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Last Updated

August 31, 2012

Status Verified

August 1, 2012

Enrollment Period

1.2 years

First QC Date

August 1, 2006

Last Update Submit

August 30, 2012

Conditions

Anemia

Keywords

darbepoetin alfaanemiacancer patientschemotherapy

Outcome Measures

Primary Outcomes (1)

  • To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response

Secondary Outcomes (3)

  • 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

Interventions

darbepoetin alfaDRUG

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Tokai region

Aichi, Japan

Location

Shikoku region

Ehime, Japan

Location

Kyusyu region

Fukuoka, Kumamoto, Japan

Location

Hokkaido region

Hokkaido, Japan

Location

Kinki region

Kyoto, Osaka, Nara, Japan

Location

Tohoku region

Miyagi, Japan

Location

Hokuriku region

Niigata, Ishikawa, Japan

Location

Kanto region

Tochigi, Saitama, Tokyo, Kanagawa, Japan

Location

MeSH Terms

Conditions

Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Nagahiro Saijo, MD

    National Cancer Center Hospital East

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2006

First Posted

August 3, 2006

Study Start

July 1, 2006

Primary Completion

September 1, 2007

Last Updated

August 31, 2012

Record last verified: 2012-08

Locations

JP(8)