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

Last updated: November 21, 2018
Sponsor: GeneScience Pharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Severe Short Stature

Treatment

N/A

Clinical Study ID

NCT03535415
GenSci GH AQ CT-CKD
  • Ages 2-14
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent of the subjects or the legal guardian.

  • Subjects and guardian are willing and able to cooperate to complete scheduledvisits,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

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 investigationalproduct 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 theinvestigator.

Study Design

Total Participants: 68
Study Start date:
June 25, 2018
Estimated Completion Date:
September 30, 2021

Connect with a study center

  • Fuzhou general hospital of Nanjing military command

    Fuzhou, Fujian
    China

    Active - Recruiting

  • The first affiliated hospital of zhengzhou university

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Tongji medical college huazhong university of science & technology

    Wuhan, Hubei
    China

    Active - Recruiting

  • Shengjing hospital of chian medical university

    Shenyang, Liaoning
    China

    Active - Recruiting

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai
    China

    Active - Recruiting

  • The Children's Hospital ,Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Beijing Children's Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • Children's hospital capital institute of pediatrics

    Beijing,
    China

    Active - Recruiting

  • Peking university first hospital

    Beijing,
    China

    Active - Recruiting

  • Children's hospital of Chongqing medical university

    Chongqing,
    China

    Active - Recruiting

  • Children's Hospital of Fudan University

    Shanghai,
    China

    Active - Recruiting

  • Children's Hospital of Shanghai

    Shanghai,
    China

    Active - Recruiting

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