An Open-label, Multi-center, Extension Study to Evaluate the Safety and Tolerability of AF37702 Injection (Hematide™) for the Long-Term Maintenance Treatment of Anemia in Patients With Chronic Kidney DiseaseAm 3.1 (13 November 2008) is site specific for the DeSilva UK site only. All other sites will comply with amendment 3.

Affymax, Inc.0 个研究点目标入组 125 人开始时间: 2008年5月20日最近更新: 2017年8月21日

试验速览

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•a. Patient is informed of the investigational nature of this study and has given written, informed consent in accordance with institutional, local, and national guidelines
•b. Males or females = 18 years of age.
•c. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 4 weeks prior to study drug administration, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some (IUDs), sexual abstinence or vasectomized partner.
•d. Patient with CKD who has received at least 24 weeks of AF37702 Injection dosing (e.g., 6 doses administered Q4W or 12 doses administered Q2W) in a previous Affymax-sponsored study.
•e. One Hgb value of = 10.0 g/dL in the 4 weeks prior to study drug administration.
•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

•a. Known intolerance to AF37702 Injection and PEGylated products
•b. History of antibodies to any erythropoiesis stimulating agent (ESA) or history of pure red cell aplasia (PRCA)
•c. High likelihood of early withdrawal or interruption of the study (e.g., patient suffers from any clinically significant medical disease or condition that may, in the Investigator’s opinion, interfere with safety, assessment, or follow-up of the patient)
•d. Anticipated life expectancy < 18 months
•e. Receipt of any commercially available ESA other than AF37702 at any time after patient enrollment in the previous Affymax-sponsored study

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