A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00359840 |
Recruitment Status :
Completed
First Posted : August 3, 2006
Last Update Posted : August 31, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anemia | Drug: darbepoetin alfa | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Dose - Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor |
Study Start Date : | July 2006 |
Actual Primary Completion Date : | September 2007 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 74 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359840
Japan | |
Tokai region | |
Aichi, Japan | |
Shikoku region | |
Ehime, Japan | |
Kyusyu region | |
Fukuoka, Kumamoto, Japan | |
Hokkaido region | |
Hokkaido, Japan | |
Kinki region | |
Kyoto, Osaka, Nara, Japan | |
Tohoku region | |
Miyagi, Japan | |
Hokuriku region | |
Niigata, Ishikawa, Japan | |
Kanto region | |
Tochigi, Saitama, Tokyo, Kanagawa, Japan |
Study Chair: | Nagahiro Saijo, MD | National Cancer Center Hospital East |
Responsible Party: | Kyowa Kirin Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00359840 |
Other Study ID Numbers: |
KRN321-SC/05-A55 |
First Posted: | August 3, 2006 Key Record Dates |
Last Update Posted: | August 31, 2012 |
Last Verified: | August 2012 |
darbepoetin alfa anemia cancer patients chemotherapy |
Anemia Hematologic Diseases Darbepoetin alfa Hematinics |