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Growth Hormone Therapy for Pediatric Chronic Kidney Disease-Associated Growth Disorders: A Real-World Study

Growth Hormone Therapy for Pediatric Chronic Kidney Disease-Associated Growth Disorders: A Real-World Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099135
Enrollment
Unknown
Registered
2025-03-19
Start date
2025-03-20
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth impairment in children with chronic kidney disease

Interventions

ambidirectional cohort study:None

Sponsors

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Subjects meet the clinical diagnosis of chronic kidney disease (CKD), which is defined by the 2012 KDIGO Clinical Practice Guidelines as a structural or functional abnormality of the kidneys that has persisted for more than 3 months and is affecting the health of the patient. (i)Proteinuria (urine albumin excretion rate =30 mg/24 h; urine albumin creatinine ratio =30mg/g); (ii) abnormal urinary sediment; (iii) electrolyte and other abnormalities due to tubular causes; (iv) histologic abnormalities; (v) structural abnormalities on imaging; (vi) history of renal transplantation; and (vii) GFR <60 mL/(min-1.73 m2). 2. Being less than P3 of a normal child of the same race, age, or sex, or having a growth rate less than P25 of the reference value for child growth rate. 3. Glucocorticoid (GC) dose reduction to <0.5mg/kg/d for more than 1 month. 2.Being less than P3 of a normal child of the same race, age, or sex, or having a growth rate less than P25 of the reference value for child growth rate. 3.The dose of glucocorticoids (GC) was reduced to <0.5 mg/kg/day for more than 1 month. 4.Treatment may be with or without other immunosuppressants. 5.Stable condition. 6.At the start of the trial, treatment with growth hormone (long-acting, aqueous and powder) is now required.

Exclusion criteria

Exclusion criteria: 1.Patients with abnormal liver function (ALT> 2 times the upper limit of normal). 2.Cardiac function was corrected with treatment, and the left ventricular ejection fraction was <50% on cardiac ultrasound. 3.Those who are allergic to growth hormone or its protective agents. 4.Patients with severe respiratory, cardiovascular, hematological, immune system and other chronic diseases or systemic infections, as well as mental illness. 5.Diabetic patients or those with abnormal fasting blood glucose (two fasting blood glucose = 6.1mmol/L). 6.Tumor patients or patients with a previous history of tumors or patients with underlying tumors (two or more first-degree relatives with a history of tumor within three generations). 7.Inability to obtain accurate altitude measurements (eg, in severe patients with scoliosis, myelomeningocele, or severe bony deformities); 8.Patients whose epiphyses have completely closed. 9.Inability to provide complete medical records or anticipation of incomplete follow-up or collection of complete medical records. 10.Other conditions that, in the opinion of the investigator, are not appropriate for enrollment in this study.

Design outcomes

Primary

MeasureTime frame
Change from baseline in height standard deviation score (HtSDS) in children with CKD after 52 weeks of growth hormone therapy (?HtSDS);

Secondary

MeasureTime frame
Safety;Change from baseline in growth rate;Bone maturity;Change in blood IGF-1 standard deviation score before and after treatment;

Countries

China

Contacts

Public ContactJianhua Zhou

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology

jhzhou99@qq.com+86 378 366 2688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026