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Completed

NCT Number: NCT00359840

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

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

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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 2

Primary location

Tokai region, Aichi, 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 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

Treatment and study plan

darbepoetin alfa

Drug

Primary outcomes

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

Secondary outcomes

  1. To compare the proportion of subjects who receive red blood cell transfusions or show the hemoglobin level below 8 g/dL

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

Important dates

Study start
2006
Primary completion
2007
First posted
Aug 3, 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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