A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation
- Conditions
- Dwarfism
- Interventions
- Drug: Recombinant Human Growth Hormone Injection (rhGH)
- Registration Number
- NCT03535415
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 68
- 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/1.73m2.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rhGH Injection Recombinant Human Growth Hormone Injection (rhGH) rhGH 0.05mg/kg/d by subcutaneous injection
- Primary Outcome Measures
Name Time Method The change of height standard deviation score of chronological age before and after treatment (ΔHT SDS) 52 weeks，104 weeks
- Secondary Outcome Measures
Name Time Method 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 365.25\*（height at the time of assessment -height at baseline）/duration of treatment(days)
Bone maturation ( bone age/ chronological age: BA/CA) 12 months, 24 months
Trial Locations
- Locations (12)
Fuzhou general hospital of Nanjing military command
🇨🇳Fuzhou, Fujian, China
The first affiliated hospital of zhengzhou university
🇨🇳Zhengzhou, Henan, China
Tongji medical college huazhong university of science & technology
🇨🇳Wuhan, Hubei, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shengjing hospital of chian medical university
🇨🇳Shenyang, Liaoning, China
The Children's Hospital ,Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Beijing Children's Hospital, Capital Medical University
🇨🇳Beijing, China
Children's hospital capital institute of pediatrics
🇨🇳Beijing, China
Children's hospital of Chongqing medical university
🇨🇳Chongqing, China
Children's Hospital of Shanghai
🇨🇳Shanghai, China
Children's Hospital of Fudan University
🇨🇳Shanghai, China
Peking university first hospital
🇨🇳Beijing, China