A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation
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
1 other identifier
interventional
68
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2018
Typical duration for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2018
CompletedFirst Posted
Study publicly available on registry
May 24, 2018
CompletedStudy Start
First participant enrolled
June 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedNovember 23, 2018
November 1, 2018
2.2 years
April 28, 2018
November 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The change of height standard deviation score of chronological age before and after treatment (ΔHT SDS)
52 weeks，104 weeks
Secondary Outcomes (4)
Growth velocity
12 months, 24 months
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
Study Arms (2)
rhGH Injection
EXPERIMENTALrhGH 0.05mg/kg/d by subcutaneous injection
Non-treatment control group
NO INTERVENTIONOnly follow-up without treatment
Interventions
rhGH 0.05mg/kg/d by subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changchun GeneScience Pharmaceutical Co., Ltd.lead
- Children's Hospital of Fudan Universitycollaborator
- Beijing Children's Hospitalcollaborator
- Shanghai Children's Hospitalcollaborator
- Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicinecollaborator
- The Children's Hospital of Zhejiang University School of Medicinecollaborator
- Children's Hospital of The Capital Institute of Pediatricscollaborator
- Peking University First Hospitalcollaborator
- Fuzhou General Hospitalcollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Shengjing Hospitalcollaborator
- Children's Hospital of Chongqing Medical Universitycollaborator
- Tongji medical college huazhong university of science & technologycollaborator
Study Sites (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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Xu, PhD
Children's Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2018
First Posted
May 24, 2018
Study Start
June 25, 2018
Primary Completion
September 1, 2020
Study Completion
September 1, 2021
Last Updated
November 23, 2018
Record last verified: 2018-11