A Randomised Single-Blind Study to Improve Health-related Quality of Life as Measured by the Short-Form 36 (SF-36) Vitality Score by Correcting Anemia With Aranesp (Darbepoetin Alfa) in the Elderly.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 51
- 主要终点
- Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24
研究概览
简要总结
Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks
详细描述
This is a multicentre, randomised, single-blind, placebo-controlled, two-arm parallel group study assessing the effect of anaemia correction and Hb maintenance with darbepoetin alfa in elderly CKD patients for 36 weeks.
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
- Single (Participant)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 3-5 CKD not on dialysis
- •Patients ≥ 70 years of age
- •Haemoglobin < 110g/L at screening
- •Transferrin saturation ≥ 15% at screening
排除标准
- •Clinical history of type 2 diabetes mellitus
- •Anticipating or scheduled to go on renal replacement therapy in the next year, including renal transplant
- •Uncontrolled hypertension on two separate measurements during screening
- •Use of any erythropoietic protein within 12 weeks of screening
研究组 & 干预措施
Darbepoetin alfa
Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
干预措施: Darbepoetin alfa (Drug)
Placebo
Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24
时间窗: Week 24
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
次要结局
- Number of Participants With Hemoglobin (Hb) ≥ 110 g/L(Evaluation Period (Weeks 22-36))
- Mean Hemoglobin During the Evaluation Period(Evaluation Period (Weeks 22-36))
- Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24(Week 24)