NCT01502137已完成1 期
An Open, Non-randomized, Single-centre, Parallel Group Trial Investigating the Steady-state Blood Concentration Profile and Effects of Once Daily Subcutaneously Injected Recombinant Human Growth Hormone (Norditropin® SimpleXx®) in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis and in Matched Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Growth hormone exposure at steady state
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to to compare steady-state total growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PATIENTS:
- •Male or female, age equal to or above 18 years undergoing chronic haemodialysis
- •Stable and adequate haemodialysis treatment three months prior to enrolment
- •HEALTHY SUBJECTS:
- •Matching an individual of the patient group by: Gender and age (± 5 years)
- •Matching an individual of the patient group by weight (after dialysis, ±10%)
- •Creatinine clearance above 80 ml/min
- •Subjects must be in good health in accordance with their age as determined by a medical
- •history, physical examination, vital signs, ECG (electrocardiogram), routine haematology and clinical chemistry
排除标准
- •Use of cuprophane membranes
- •Active malignant disease
- •Critical illness as defined by the need of respiratory or circulatory support
- •Known or suspected allergy to the trial product
- •Pregnancy, breast feeding, the intention of becoming pregnant or fertile women judged to be
- •using inadequate contraceptive measures
- •Blood Pressure (pre-dialysis) above 180/110
- •Chronic treatment with steroids in doses above 10 mg/day prednisolone (or equivalent)
- •Treated with immunosuppressive agents
研究组 & 干预措施
ESRD patients
Experimental
干预措施: somatropin (Drug)
Healthy subjects
Experimental
干预措施: somatropin (Drug)
结局指标
主要结局
Growth hormone exposure at steady state
次要结局
- t½ (terminal half-life)
- Cmax (maximum plasma concentration)
- Area under the Curve (AUC)
- Adverse events (AE)
- IGF-I (Insulin-Like Growth Factor I)
- tmax (time to reach maximum)
研究者
研究点 (1)
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