A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation

• Status: Unknown status
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Collaborators: Beijing Children's Hospital; Children's hospital capital institute of pediatrics; Children's Hospital of Chongqing Medical University; Children's Hospital of Fudan University; Children's Hospital of Shanghai; Children's Hospital of The Capital Institute of Pediatrics; Fuzhou General Hospital; Peking University First Hospital; Shanghai Children's Hospital; Shengjing Hospital; The Children's Hospital of Zhejiang University School of Medicine; The First Affiliated Hospital of Zhengzhou University; Tongji medical college huazhong university of science & technology; Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
• Treatments: Hormones

Criteria

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.