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Completed

NCT Number: NCT00344409

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

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

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shikoku region, Ehime, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

darbepoetin alfa

Drug

Primary outcomes

  1. To compare the proportion of subjects who reach red blood cell transfusion trigger

Secondary outcomes

  1. To compare the effectiveness of KRN321 on the proportion of subjects achieving hemoglobin response

  2. To compare the proportion of subjects who receive red blood cell transfusions

  3. To compare the effectiveness of KRN321 based on quality of life scores

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Double-blind, Placebo Controlled, Randomized Study of KRN321 for the Treatment of Anemia in Cancer Patients

Important dates

Study start
2006
Primary completion
2007
First posted
Jun 26, 2006
Registry last updated
Aug 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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