A Phase 2, Open-label, Multi-center, Sequential Dose Finding Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Multiple Doses of AF37702 Injection (HematideTM) in Chronic Kidney Disease Patients Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment - AFX01-04

Affymax, Inc.0 个研究点目标入组 180 人开始时间: 2005年6月28日最近更新: 2012年4月24日

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•The subject has signed a written, witnessed informed consent. Males or females, including women of childbearing potential on a highly effective method of birth control, age 18 - 85 years. GFR of = 60 mL/min. Hemoglobin = 9.0 and < 11.0 g/dL, serum ferritin =100 µg/L and transferrin saturation = 20%, serum or red cell folate and vitamin B12 levels above the lower limits of normal, weight = 45 kg, WBC = 3.0 x10^9/L, platelet count = 100 x10^9/L.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Any previous exposure to investigational or commercially available erythropoiesis stimulating agents (ESAs) in the 12 weeks prior to study enrollment, prior treatment with Eprex, intolerance of any ESA. History of PRCA. RBC transfusion within 12 weeks. Hemoglobinopathy, hemolysis, inflammatory disease, CRP > 30 mg/L, significant infection, febrile illness, hyperparathyroidism, poorly controlled hypertension, epileptic seizures, CHF (NYHA Class IV). Significant medical diseases or conditions, including history of MI, coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric or neurological abnormalities, liver disease, active HIV disease, significant history of multiple drug allergies, or other diseases within the past 6 months that may interfere with patient assessment. Malignancy within past 5 years, life-expectancy < 12 months, anticipated elective surgery, previous exposure to any investigational drug within prior 6 weeks or expected during the study.

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