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

Dwarfism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03535415
• Other study ID #: GenSci GH AQ CT-CKD
• Status: Recruiting
• Phase: Phase 3
• Start date: June 25, 2018
• Est. completion date: September 2021

Study information

• Verified date: November 2018
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Xiaohua Feng
• Phone: 13610794989
• Email: fengxiaohua[@]gensci-china.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dwarfism
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Recombinant Human Growth Hormone Injection (rhGH)
rhGH 0.05mg/kg/d by subcutaneous injection

Locations

Country	Name	City	State
China	Beijing Children's Hospital, Capital Medical University	Beijing
China	Children's hospital capital institute of pediatrics	Beijing
China	Peking university first hospital	Beijing
China	Children's hospital of Chongqing medical university	Chongqing
China	Fuzhou general hospital of Nanjing military command	Fuzhou	Fujian
China	The Children's Hospital ,Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Children's Hospital of Fudan University	Shanghai
China	Children's Hospital of Shanghai	Shanghai
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shengjing hospital of chian medical university	Shenyang	Liaoning
China	Tongji medical college huazhong university of science & technology	Wuhan	Hubei
China	The first affiliated hospital of zhengzhou university	Zhengzhou	Henan

Sponsors (13)

Lead Sponsor

Collaborator

GeneScience Pharmaceuticals Co., Ltd.

Beijing Children's Hospital, Children's Hospital of Chongqing Medical University, Children's Hospital of Fudan University, 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of height standard deviation score of chronological age before and after treatment (?HT SDS)		52 weeks,104 weeks
Secondary	Growth velocity	365.25*(height at the time of assessment -height at baseline)/duration of treatment(days)	12 months, 24 months
Secondary	Bone maturation ( bone age/ chronological age: BA/CA)		12 months, 24 months
Secondary	IGF-1 (Insulin-like growth factor 1) SDS		12 months, 24 months
Secondary	IGF-1/IGFBP-3 molar ratio		12 months, 24 months