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

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ClinicalTrials.gov Identifier: NCT03535415
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : November 22, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Dwarfism Drug: Recombinant Human Growth Hormone Injection (rhGH) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rhGH Injection
rhGH 0.05mg/kg/d by subcutaneous injection
Drug: Recombinant Human Growth Hormone Injection (rhGH)
rhGH 0.05mg/kg/d by subcutaneous injection

No Intervention: Non-treatment control group
Only follow-up without treatment



Primary Outcome Measures :
  1. The change of height standard deviation score of chronological age before and after treatment (ΔHT SDS) [ Time Frame: 52 weeks,104 weeks ]

Secondary Outcome Measures :
  1. Growth velocity [ Time Frame: 12 months, 24 months ]
    365.25*(height at the time of assessment -height at baseline)/duration of treatment(days)

  2. Bone maturation ( bone age/ chronological age: BA/CA) [ Time Frame: 12 months, 24 months ]
  3. IGF-1 (Insulin-like growth factor 1) SDS [ Time Frame: 12 months, 24 months ]
  4. IGF-1/IGFBP-3 molar ratio [ Time Frame: 12 months, 24 months ]


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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535415


Contacts
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Contact: Xiaohua Feng 13610794989 fengxiaohua@gensci-china.com

Locations
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China, Fujian
Fuzhou general hospital of Nanjing military command Recruiting
Fuzhou, Fujian, China
Contact: Zihua Yu         
China, Henan
The first affiliated hospital of zhengzhou university Recruiting
Zhengzhou, Henan, China
Contact: Jianjiang Zhang         
China, Hubei
Tongji medical college huazhong university of science & technology Recruiting
Wuhan, Hubei, China
Contact: Jianhua Zhou         
China, Liaoning
Shengjing hospital of chian medical university Recruiting
Shenyang, Liaoning, China
Contact: Yubin Wu         
China, Shanghai
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China
Contact: Yufeng Li         
China, Zhejiang
The Children's Hospital ,Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China
Contact: Jianhua Mao         
China
Beijing Children's Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Ying Shen         
Children's hospital capital institute of pediatrics Recruiting
Beijing, China
Contact: Chaoying Chen         
Peking university first hospital Recruiting
Beijing, China
Contact: Huijie Xiao         
Children's hospital of Chongqing medical university Recruiting
Chongqing, China
Contact: Mo Wang         
Children's Hospital of Fudan University Recruiting
Shanghai, China
Contact: Hong Xu         
Children's Hospital of Shanghai Recruiting
Shanghai, China
Contact: Wenyan Huang         
Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
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
Investigators
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Principal Investigator: Hong Xu, PhD Children's Hospital of Fudan University

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Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03535415     History of Changes
Other Study ID Numbers: GenSci GH AQ CT-CKD
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dwarfism
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs