A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation
NCT ID: NCT03535415
Last Updated: 2018-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
68 participants
INTERVENTIONAL
2018-06-25
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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rhGH Injection
rhGH 0.05mg/kg/d by subcutaneous injection
Recombinant Human Growth Hormone Injection (rhGH)
rhGH 0.05mg/kg/d by subcutaneous injection
Non-treatment control group
Only follow-up without treatment
No interventions assigned to this group
Interventions
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Recombinant Human Growth Hormone Injection (rhGH)
rhGH 0.05mg/kg/d by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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 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.
2 Years
14 Years
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Beijing Children's Hospital
OTHER
Shanghai Children's Hospital
OTHER
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
UNKNOWN
The Children's Hospital of Zhejiang University School of Medicine
OTHER
Children's Hospital of The Capital Institute of Pediatrics
OTHER
Peking University First Hospital
OTHER
Fuzhou General Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Shengjing Hospital
OTHER
Children's Hospital of Chongqing Medical University
OTHER
Tongji medical college huazhong university of science & technology
UNKNOWN
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hong Xu, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Fudan University
Locations
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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
Shengjing hospital of chian medical university
Shenyang, Liaoning, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 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
Peking university first hospital
Beijing, , China
Children's hospital of Chongqing medical university
Chongqing, , China
Children's Hospital of Fudan University
Shanghai, , China
Children's Hospital of Shanghai
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Zihua Yu
Role: primary
Jianjiang Zhang
Role: primary
Jianhua Zhou
Role: primary
Yubin Wu
Role: primary
Yufeng Li
Role: primary
Jianhua Mao
Role: primary
Ying Shen
Role: primary
Chaoying Chen
Role: primary
Huijie Xiao
Role: primary
Mo Wang
Role: primary
Hong Xu
Role: primary
Wenyan Huang
Role: primary
Other Identifiers
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GenSci GH AQ CT-CKD
Identifier Type: -
Identifier Source: org_study_id
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