Status:

COMPLETED

A Double-blind Study of KRN321 for the Treatment of Anemia in Cancer Patients

Lead Sponsor:

Kyowa Kirin Co., Ltd.

Conditions:

Anemia

Eligibility:

All Genders

20-74 years

Phase:

PHASE3

Brief Summary

To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer patients receiving multi cycle platinum-containing chemotherapy

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2006

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00344409

Start Date

March 1 2006

Last Update

August 31 2012

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Shikoku region

Ehime, Japan

2

Kyusyu region

Fukuoka, Kagoshima, Japan

3

Chugoku region

Hiroshima, Tottori, Japan

4

Tohoku region

Iwate, Miyagi, Japan