Chronic kidney disease
Conditions
Interventions
Control group:None
Treatment group [Recombinant human growth hormone(Changchun Genescience)/Polyethylene glycol recombinant human somatropin(Changchun Genescience)]:None
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.Subjects fulfilled the clinical diagnosis of chronic kidney disease.The 2012 KDIGO clinical practice guidelines defined CKD as abnormalities of renal structure or function persisting for more than 3 months and affecting the health of the patient.CKD was determined by GFR<60 mL/(min·1.73 m^2)or presence of 1 or more of the following with duration of more than 3 months: 1 )proteinuria (urinary albumin excretion rate =30 mg/24 h; urinary albumin creatinine ratio =30 mg/g); 2) abnormal urinary sediment; 3) electrolytes and other abnormalities due to tubular causes; 4) abnormal histological detection; 5) abnormal imaging detection of structural abnormalities; and 6) history of kidney transplantation. 2.G3-5 in CKD (i.e. GFR<60 mL/(min·1.73 m^2); 3.P3 or - 2 SDS for children with normal height below age-matched, same-sex. 4.Correction of nutritional status, anemia, secondary hyperparathyroidism, metabolic acidosis, improve dialysis adequacy, etc. 5.Glucocorticoids (GCs) were dose-reduced to <0.5mg/kg/d for more than 1 month. 6.Combined or not with other immunosuppressive therapy. 7.Prepubertal children, aged =2 years, without regard to sex. 8.None had received a kidney transplant. 9.None receiving growth hormone therapy;
Exclusion criteria
Exclusion criteria: 1.those with abnormal liver function (ALT >1.5 times the upper limit of normal). 2.Hepatitis B virus tests were positive for HBeAb, HbsAg, and HbeAg. 3.Cardiac function was corrected with treatment,and cardiac B-ultrasound assessed left ventricular ejection fraction<50%. 4.Allergy to growth hormone or its protective agents. 5.Patients with severe chronic diseases of the respiratory system, cardiovascular system, blood system, immune system, or systemic infections, as well as mental illness. 6.patients with diabetes mellitus or those with abnormal fasting glucose (=6.1mmol/L on two occasions). 7.Patients with a tumor or a history of previous or underlying tumors (two or more or more first-degree relatives within three generations with a history of tumors). 8.Growth and development abnormalities due to other etiologies. 9.Accurate height measurements (e.g., severe patient scoliosis, spinal meningocele, or severe bony malformation) cannot be obtained. 10.Participated in clinical trials of other drugs within 3 months. 11.Other drugs that may affect growth hormone therapy were used within 3 months. 12.Other circumstances considered by the investigator not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in standard deviation score of height (HtSDS) from before treatment after 1 year (52 weeks) of treatment (?HtSDS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in growth rate after treatment compared with before treatment;Changes in bone maturity after treatment compared to before treatment;Changes in blood IGF-1 standard deviation score after treatment compared to before treatment; | — |
Countries
China
Contacts
Public ContactZhang Jianjiang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed