Dwarfism
Conditions
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.
Interventions
DRUGRecombinant Human Growth Hormone Injection (rhGH)
rhGH 0.05mg/kg/d by subcutaneous injection
Sponsors
Children's Hospital of Fudan University
Beijing Children's Hospital
Shanghai Children's Hospital
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
The Children's Hospital of Zhejiang University School of Medicine
Children's Hospital of The Capital Institute of Pediatrics
Peking University First Hospital
Fuzhou General Hospital
The First Affiliated Hospital of Zhengzhou University
Shengjing Hospital
Children's Hospital of Chongqing Medical University
Tongji medical college huazhong university of science & technology
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of height standard deviation score of chronological age before and after treatment (ΔHT SDS) | 52 weeks，104 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| IGF-1 (Insulin-like growth factor 1) SDS | 12 months, 24 months | — |
| IGF-1/IGFBP-3 molar ratio | 12 months, 24 months | — |
Countries
China
Contacts
Primary ContactXiaohua Feng
Outcome results
None listed