Study of Aranesp to Treat Anemia in Prostate Cancer Patients.

Exclusion Criteria

• •Patients presenting an active primary or metastatic malignancy involving the CNS. Patients with a previous history of primary or metastatic malignancy involving the CNS will be eligible for the study, if they have had no clinical signs or symptoms of, not treatment for CNS disease, and no history of seizures within the previous 2 years.
• •Patients receiving rHuEPO therapy within 4 weeks prior to first dose of the study drug.
• •Active bleeding or RBC transfusion within 4 weeks prior to fist dose of study drug.
• •Patients with an active seizure disorder. Patients with a previous history of seizure disorder will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of anti-convulsant medication for the previous 5 years.
• •Patients with uncontrolled angina, congestive heart failure or uncontrolled cardiac arrhythmia.
• •Patients with uncontrolled hypertension
• •Patients with a history of hyperviscosity syndrome
• •Patients with evidence of clinically significant systemic active infection or inflammatory disease
• •Patients with known positive test for human immunodeficiency virus (HIV) infection
• •Patients with inadequate iron stores (Fe/TIBC less than 15% and ferritin less than 10.0 mg/L)
• •Patients with a history or any primary hematologic disorder that could cause anemia
• •Patients currently receiving, or not yet 30 days past receiving (prior to the first dose of study drug), other investigational agents or devices not approved in any indication by the governing regulatory authority. Note: an exception will be made for patients receiving DN-101, a new formulation of calcitriol, on an investigational study.
• •Patients who have previously received Aranesp (darbepoetin alfa) within 4 weeks prior to fist dose of study drug.
• •Patients with a known hypersensitivity to the active substance or any of the excipients.