An Open-Label Study to Investigate Improvement in Heart Function After Complete Anemia Correction With NeoRecormon in Patients With End-Stage Renal Disease Already Receiving Sub-Optimal Doses of NeoRecormon
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Hb level, BP.
研究概览
简要总结
This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart function and quality of life will be measured before and after anemia correction. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-75 years of age;
- •end-stage renal disease;
- •on renal dialysis >= 3 months;
- •receiving NeoRecormon treatment >= 3 months;
- •Hb stable and <105g/L, and LVMI >160g/m2.
排除标准
- •unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;
- •use of any ESA other than NeoRecormon;
- •acute infection;
- •use of iv NeoRecormon.
研究组 & 干预措施
1
干预措施: epoetin beta [NeoRecormon] (Drug)
结局指标
主要结局
Hb level, BP.
时间窗: Throughout study
LVMI ejection fraction, ejection fraction.
时间窗: 12 months
次要结局
- SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.(Throughout study)