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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

Primary Purpose

Dwarfism

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Recombinant Human Growth Hormone Injection (rhGH)
Sponsored by
Changchun GeneScience Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dwarfism

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fuzhou general hospital of Nanjing military commandRecruiting
  • The first affiliated hospital of zhengzhou universityRecruiting
  • Tongji medical college huazhong university of science & technologyRecruiting
  • Shengjing hospital of chian medical universityRecruiting
  • Xinhua Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
  • The Children's Hospital ,Zhejiang University School of MedicineRecruiting
  • Beijing Children's Hospital, Capital Medical UniversityRecruiting
  • Children's hospital capital institute of pediatricsRecruiting
  • Peking university first hospitalRecruiting
  • Children's hospital of Chongqing medical universityRecruiting
  • Children's Hospital of Fudan UniversityRecruiting
  • Children's Hospital of ShanghaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

rhGH Injection

Non-treatment control group

Arm Description

rhGH 0.05mg/kg/d by subcutaneous injection

Only follow-up without treatment

Outcomes

Primary Outcome Measures

The change of height standard deviation score of chronological age before and after treatment (ΔHT SDS)

Secondary Outcome Measures

Growth velocity
365.25*（height at the time of assessment -height at baseline）/duration of treatment(days)
Bone maturation ( bone age/ chronological age: BA/CA)
IGF-1 (Insulin-like growth factor 1) SDS
IGF-1/IGFBP-3 molar ratio

Full Information

First Posted
April 28, 2018
Last Updated
November 21, 2018
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
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
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1. Study Identification

Unique Protocol Identification Number
NCT03535415
Brief Title
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
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

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dwarfism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rhGH Injection
Arm Type
Experimental
Arm Description
rhGH 0.05mg/kg/d by subcutaneous injection
Arm Title
Non-treatment control group
Arm Type
No Intervention
Arm Description
Only follow-up without treatment
Intervention Type
Drug
Intervention Name(s)
Recombinant Human Growth Hormone Injection (rhGH)
Intervention Description
rhGH 0.05mg/kg/d by subcutaneous injection
Primary Outcome Measure Information:
Title
The change of height standard deviation score of chronological age before and after treatment (ΔHT SDS)
Time Frame
52 weeks，104 weeks
Secondary Outcome Measure Information:
Title
Growth velocity
Description
365.25*（height at the time of assessment -height at baseline）/duration of treatment(days)
Time Frame
12 months, 24 months
Title
Bone maturation ( bone age/ chronological age: BA/CA)
Time Frame
12 months, 24 months
Title
IGF-1 (Insulin-like growth factor 1) SDS
Time Frame
12 months, 24 months
Title
IGF-1/IGFBP-3 molar ratio
Time Frame
12 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohua Feng
Phone
13610794989
Email
fengxiaohua@gensci-china.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Xu, PhD
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuzhou general hospital of Nanjing military command
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zihua Yu
Facility Name
The first affiliated hospital of zhengzhou university
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianjiang Zhang
Facility Name
Tongji medical college huazhong university of science & technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Zhou
Facility Name
Shengjing hospital of chian medical university
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yubin Wu
Facility Name
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yufeng Li
Facility Name
The Children's Hospital ,Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Mao
Facility Name
Beijing Children's Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Shen
Facility Name
Children's hospital capital institute of pediatrics
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaoying Chen
Facility Name
Peking university first hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huijie Xiao
Facility Name
Children's hospital of Chongqing medical university
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mo Wang
Facility Name
Children's Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Xu
Facility Name
Children's Hospital of Shanghai
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyan Huang

12. IPD Sharing Statement

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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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