An Open-Label, Multi-Center, Extension Study to Evaluate the Safety and Tolerability of Peginesatide for the Long-Term Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Final Dosing Guideline Change
研究概览
简要总结
The purpose of this study was to evaluate the long term safety and tolerability of peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.
详细描述
Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure.
Erythropoiesis stimulating agents (ESAs) have been established as a treatment for anemia in subjects with chronic kidney disease, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia associated with chronic kidney disease. Peginesatide binds to and activates the human erythropoietin receptor, and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents.
Study participants had received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study and were to receive doses of peginesatide for up to 54 months. However, the Sponsor ended the study early.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is informed of the investigational nature of this study and has given written, informed consent in accordance with institutional, local, and national guidelines.
- •Males or females ≥ 18 years of age.
- •Premenopausal 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.
- •Participant who has received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study.
- •One hemoglobin value of ≥ 10.0 grams per deciliter (g/dL) in the 4 weeks prior to study drug administration.
排除标准
- •Known intolerance to peginesatide or pegylated products.
- •History of antibodies to any erythropoiesis stimulating agent (ESA) or history of pure red cell aplasia (PRCA).
- •High likelihood of early withdrawal or interruption of the study (e.g., participant 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 participant)
- •Anticipated life expectancy < 18 months
- •Receipt of any ESA other than peginesatide at any time after participant enrollment in the previous Affymax-sponsored study
研究组 & 干预措施
Maintenance Switch in Dialysis Participants
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). This group is categorized as "Maintenance Switch in Dialysis Participants" regardless of dialysis status at the start of or during this study.
干预措施: peginesatide (Drug)
Treatment Initiation in Non-Dialysis Participants
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). This group is categorized as "Initiation of Treatment in Non-Dialysis Participants" regardless of dialysis status at the start of or during this study.
干预措施: peginesatide (Drug)
结局指标
主要结局
Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Final Dosing Guideline Change
时间窗: Up to 54 months
次要结局
未报告次要终点