NCT00440063终止4 期
A Randomized Study to Compare the Safety and Effectiveness of Two Monitoring Schedules to Maintain Hemoglobin Levels and Iron Parameters in Patients With Renal Anemia Receiving NeoRecormon
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 试验地点
- 9
- 主要终点
- Percentage of patients achieving target Hb within 20 weeks.
研究概览
简要总结
This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. Patients with chronic kidney disease will receive NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters, either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 inidividuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-80 years of age;
- •stage 3-4 chronic kidney disease (eGFR 15-60mL/min);
- •Hb <100g/L, TSAT>=20%, and ferritin >=100 mcg/L at screening.
排除标准
- •anticipating to go on renal replacement therapy;
- •anticipating a living related-donor kidney transplant, or a prior recipient of a kidney transplant;
- •uncontrolled hypertension;
- •congestive heart failure;
- •active bleeding or red blood cell transfusions in 8 weeks prior to screening; systematic hematological disease.
结局指标
主要结局
Percentage of patients achieving target Hb within 20 weeks.
次要结局
- Efficacy: % of patients exceeding upper Hb target; % who fail to reach target Hb; median time to achieve Hb target; dose of NeoRecormon required to meet target Hb concentration; % who maintain target iron parameters. Safety: AEs, SAEs.
研究者
研究点 (9)
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