This is an open - label study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SG301 Subcutaneous injection in children with frequently relapsing or steroid - dependent nephrotic syndrome.
Aged 6 - 18 years.
Steroid-sensitive nephrotic syndrome with frequent relapses (FRNS) or steroid dependence (SDNS).
Normal renal function: eGFR≥90 ml/min/1.73m².
After steroid treatment, morning urine protein<1 + or urine protein/creatinine<0.2 g/g (<20 mg/mmol) for ≥3 consecutive days.
Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia.
Alanine aminotransferase >2×ULN or total bilirubin>2×ULN with a sustained increase for 2 weeks.
HBsAg or HBcAb positive with Hepatitis B virus DNA above the lower limit of normal; Hepatitis C virus antibody - positive with Hepatitis C virus RNA positive; HIV antibody - positive.
Chronic active infections (e.g., Epstein-Barr Virus, Cytomegalovirus, tuberculosis) that may worsen with steroids/ immunosuppressants.
Single group
SG301 Subcutaneous injection
DrugSubcutaneous injection every weeks (QW\*6),subsequently, administer it once every two weeks for a total of three times (Q2W\*3). The total number of doses is nine.
Incidence and rate of treatment-Emergent Adverse Events
Number and percentage of adverse events which are calculated by worst CTCAE grade by CTCAE 5.0
Relapse free survival rate
Relapse free survival rate at 6 and 12 months
Relapse frequency in times
Proportion of relapsed participants
Time to Relapse
Time to first relapse after enrollment
Serum creatinine
Serum creatinine(SCr), SCr in mg/dl
estimated glomerular filtration rate
Estimated glomerular filtration rate (eGFR), eGFR in ml/min/1.73m²
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Mao Jianhua
Lead sponsor
The Children's Hospital of Zhejiang University School of Medicine
Sponsor institution
