Efficacy and Safety of Somatropin in Adult Patients on Chronic Haemodialysis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 712
- 试验地点
- 1
- 主要终点
- Mortality - Time to All-cause Death
研究概览
简要总结
This trial is conducted in Africa, Asia, Europe, North and South America and Oceania.
The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health related quality of life in adult patients on chronic haemodialysis.
详细描述
The decision to discontinue the trial is not due to safety concerns. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is expected to have a negative impact on the outcome of the trial.
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
- Double (Participant, Investigator)
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
- •Serum albumin as specified in protocol
- •Malnourished (based on serum albumin value below 40 g/L, assessed centrally)
- •Stable (for 3 months or more) and adequate haemodialysis treatment three months prior to enrolment as defined by Kt/V of more than 1.2
排除标准
- •Active malignant disease
- •Critical illness requiring treatment in an intensive care unit (ICU)
- •Uncontrolled treated/untreated hypertension
- •Patients on chronic (more than 3 months) treatment with steroids in doses of more than 10 mg/day prednisolone (or equivalent)
- •Patients treated with immunosuppressive agents
- •Known Growth Hormone Deficiency
- •Patients suffering from any clinically significant disease history in the opinion of the investigator
- •Severe illness as defined in the protocol (as judged by the investigator)
研究组 & 干预措施
Placebo
Placebo once daily to end of trial
干预措施: placebo (Drug)
Somatropin
Somatropin once daily from week 0 to end of trial
干预措施: somatropin (Drug)
结局指标
主要结局
Mortality - Time to All-cause Death
时间窗: week 0, trial termination
Time to all-cause death. Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants dead estimated using Kaplan-Meier. Summary data illustrates mortality until 52 weeks, because very few subjects had trial time longer than 52 weeks. Due to early trial termination, median trial time was 17.4 weeks.
次要结局
- Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis Procedures(week 0, trial termination)
- Morbidity - Time From Randomisation to Next Cardiovascular Event (Defined as Composite of All-cause Mortality, Non-fatal Myocardial Infarction, Stroke, Cardiac Insufficiency and Other Thrombo-embolic Event)(week 0, trial termination)
- Mortality - Two-year Mortality Rate(week 0, trial termination)
- Health Related Quality of Life Assessments(week 0, trial termination)