Status:
COMPLETED
Study for the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.
Lead Sponsor:
Amgen
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle chemotherapy.
Detailed Description
The purpose of this study is to compare the effect of darbepoetin alfa and Epoetin alfa for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.
Eligibility Criteria
Inclusion
- Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Subjects must provide written informed consent
Exclusion
- Known history of seizure disorder - Known primary hematologic disorder causing anemia other than non-myeloid malignancies - Unstable / uncontrolled cardiac condition - Clinically significant inflammatory disease - Known positive test for HIV infection - Neutralizing antibodies to rHuEPO - Epoetin alfa or darbepoetin alfa therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - Pregnant or breast feeding - Not using adequate contraceptive precautions - Previously randomized into this study - Known hypersensitivity to recombinant mammalian-derived product - Concerns for subject's compliance
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00148421
Last Update
May 15 2013
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