NCT00869856撤回3 期
An Open Label, Single-arm, Baseline-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 Administered Once a Week (qw) and Once Every Two Weeks (q2w) in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Sandoz
- 试验地点
- 18
- 主要终点
- Change in hemoglobin level
研究概览
简要总结
This is an open-label, single-arm, baseline-controlled, multicenter efficacy and safety switch study involving 500 CKD subjects suffering from anemia and treated previously with a stable dose of ESA s.c.
Correction of anemia will be maintained by s.c. administration of HX575 in two frequencies (i.e. qw and q2w), in order to maintain an Hb target range of 10.0-12.0 g/dL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Male and female CKD subjects with or without dialysis treatment
- •Age > 18 years
- •Subjects under documented stable maintenance therapy with ESA, s.c. at least once per week and in accordance with the relevant SmPC, for at least 3 months with a total weekly dose of ≤ 300 IU/kg/week
- •Subjects with controlled symptomatic anemia, defined as mean Hb level between 10.0 g/dL and 12.0 g/dL, based on four Hb measurements during the four-week baseline period
- •Adequate iron status, serum ferritin ≥ 100 µg/L or transferrin saturation ≥ 20%
- •Confirmed negative anti-EPO antibody assay from sample taken at screening visit -4
排除标准
- •Systemic cyclosporine
- •History of PRCA or aplastic anemia
- •History of anti-EPO antibodies
- •Uncontrolled hypertension
研究组 & 干预措施
1
Experimental
HX575, EPO Hexal
干预措施: HX575 solution for s.c. administration (Drug)
结局指标
主要结局
Change in hemoglobin level
时间窗: 36 weeks
次要结局
- To document the safety and lack of immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration.(36 weeks)
研究者
研究点 (18)
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