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

Changchun GeneScience Pharmaceutical Co., Ltd.12 sites in 1 country68 target enrollmentJune 25, 2018

ConditionsDwarfism

InterventionsRecombinant Human Growth Hormone Injection (rhGH)

Overview

Phase: Phase 3
Intervention: Recombinant Human Growth Hormone Injection (rhGH)
Conditions: Dwarfism
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Enrollment: 68
Locations: 12
Primary Endpoint: The change of height standard deviation score of chronological age before and after treatment (ΔHT SDS)
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 25, 2018

End Date

September 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

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/1.73m
•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.