A Phase 3b Single-Arm, Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Percentage of Participants Undergoing Conversion to Peginesatide Injection
研究概览
简要总结
The purpose of this study is to understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.
详细描述
Monthly Erythropoiesis-Stimulating Agents (ESA) dosing, compared with the longstanding practice of dosing three times per week, represents a significant change in anemia treatment for dialysis patients. Because of the differences in the processes needed to support monthly dosing versus thrice weekly dosing, there is a need to prospectively identify and evaluate factors in the dialysis environment during center-level transition of patients from one ESA to another.
AFX01-18 is a Phase 3b open-label, single-arm conversion study that was conducted at 5 hemodialysis sites in the United States, and enrolled Chronic Kidney Disease (CKD) patients receiving outpatient, in-center hemodialysis. The study treatment period was approximately 12 months in duration. Participants received peginesatide injection for approximately six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Have provided written informed consent in accordance with institutional, local, and national guidelines
- •Are ≥18 years of age at the start of screening
- •Have been on in-center hemodialysis for ≥12 weeks at the start of screening
- •Are currently maintained on Epoetin at the start of screening
- •If sexually active and a female of childbearing potential, are willing to use highly effective method of birth control ≥4 weeks before study enrollment and through the study
- •If a female of childbearing potential, have a negative pregnancy test during screening
排除标准
- •Are scheduled for a renal transplantation during study (Note: patients awaiting transplantation with no date scheduled may enroll.)
- •Have an active malignancy or malignancy treated within one year prior to the start of screening for curative or palliative intent (Note: patients with non-melanoma skin cancers may enroll.)
- •Have known intolerance to any ESA or PEGylated molecule
- •Have been exposed to any investigational agent during the four weeks prior to the start of screening or are anticipated to receive such agents during the study
- •Have any significant medical or psychiatric condition judged by the investigator to prevent informed consent or study compliance
- •Are pregnant or nursing
研究组 & 干预措施
peginesatide injection
In the first 6 months participants received standard of care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1-week erythropoiesis-stimulating agent (ESA)-Free Period, followed by peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
干预措施: Epoetin (Drug)
peginesatide injection
In the first 6 months participants received standard of care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1-week erythropoiesis-stimulating agent (ESA)-Free Period, followed by peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
干预措施: Peginesatide (Drug)
结局指标
主要结局
Percentage of Participants Undergoing Conversion to Peginesatide Injection
时间窗: 6 months
次要结局
- Peginesatide Dosing(Month 6 - 12)
- Peginesatide Dose Deviations(Months 6 - 12)
- Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL(Months 1, 2, 3, 4, 5 and 6 of each treatment period)
- Percentage of Participants Who Received at Least One Intravenous Iron Dose(12 months)
- Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion(12 months)