NCT03535415Unknown3 期
A Phase 3 Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 68
- 试验地点
- 12
- 主要终点
- The change of height standard deviation score of chronological age before and after treatment (ΔHT SDS)
研究概览
简要总结
This study aims to evaluate the efficacy and safety of recombinant human growth hormone injection in short stature children due to chronic kidney disease before transplantation.
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
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent of the subjects or the legal guardian.
- •Subjects and guardian are willing and able to cooperate to complete scheduled visits,treatment plans and laboratory tests and other procedures.
- •Diagnosed as chronic kidney disease.
- •Glomerular filtration rate (GFR) <75ml/per min/1.73m
- •After the treatment and adjustment of hypertension, anemia, metabolic acidosis, malnutrition, renal osteopathy, hypothyroidism, etc..
- •Chronological age: ≥2years and ≤14years.
- •Height Standard Deviation Score(HtSDS) ≤-2SD for chronological age.
- •Bone age: girls≤10 years; boys≤11years.
- •Pre-pubertal (Tanner Stage I ) patients.
- •No history of growth hormone treatment.
排除标准
- •Subjects with abnormal liver functions.
- •Subjects positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests.
- •After adjustment heart function,Cardiac ejection fraction(EF) <50%.
- •Subjects with highly allergic constitution or allergy to proteins or investigational product or its excipient.
- •Subjects with systemic chronic disease or general infection or mental disease.
- •Subjects with diabetes or impaired fasting glucose.
- •Subjects with tumor or potential tumor.
- •Subjects who are using glucocorticoid or immunosuppressant.
- •Other causes for growth retardation.
- •Inability to obtain accurate height measurements.
- •Subjects who took part in other clinical trials within 3 months.
- •Concomitant administration of other treatment that may have an effect on growth within 3 months.
- •Other conditions which are unsuitable for this study in the opinion of the investigator.
研究组 & 干预措施
rhGH Injection
Experimental
rhGH 0.05mg/kg/d by subcutaneous injection
干预措施: Recombinant Human Growth Hormone Injection (rhGH) (Drug)
结局指标
主要结局
The change of height standard deviation score of chronological age before and after treatment (ΔHT SDS)
时间窗: 52 weeks，104 weeks
次要结局
- IGF-1 (Insulin-like growth factor 1) SDS(12 months, 24 months)
- IGF-1/IGFBP-3 molar ratio(12 months, 24 months)
- Growth velocity(12 months, 24 months)
- Bone maturation ( bone age/ chronological age: BA/CA)(12 months, 24 months)
研究者
研究点 (12)
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