Frequently relapsing nephrotic syndrome,FRNS,Steroid-dependent nephrotic syndrome,SDNS
Conditions
Interventions
Experimental group:Enrolled study participants will be treated with subcutaneous injection of 12 mg/kg SG301 SC injection. The dose was given once weekly for the first 6 weeks, followed by three doses
Sponsors
Children's Hospital,Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.Age??: 6–18 years.; 2.??Diagnosis??: Steroid-sensitive nephrotic syndrome (SSNS) with ??frequently relapsing (FRNS)?? or ??steroid-dependent (SDNS)?? status.; 3.Renal Function??: Estimated glomerular filtration rate (eGFR) >= 90 ml/min/1.73m^2; 4.Disease Activity Control??: Morning urine protein 80 g/L without growth factor support or transfusion. 6.Coagulation Profile??: Prothrombin time (PT)/International Normalized Ratio (INR) =6 months before enrollment.
Exclusion criteria
Exclusion criteria: 1.Family History??: History of nephrotic syndrome, chronic glomerulonephritis, or uremia in first-degree relatives; 2.Hepatic Dysfunction??: Alanine aminotransferase (ALT) > 2 × upper limit of normal (ULN) ??or?? total bilirubin > 2 × ULN, ??persisting for =2 weeks??; 3.??Viral Infections??: ??Hepatitis B??: HBsAg-positive ??or?? HBcAb-positive with detectable HBV DNA above the lower limit of normal. ??Hepatitis C??: Anti-HCV antibody-positive with detectable HCV RNA. ??HIV??: Anti-HIV antibody-positive; 4.Chronic Active Infections??: Active EBV, cytomegalovirus (CMV), or Mycobacterium tuberculosis infection, ??where cortico;steroids/immunosuppressants may exacerbate the condition??; 5.Acute Infections??: Acute active infection requiring systemic antibiotics/antivirals (excluding fungal nail bed infections); 6.Secondary or Resistant Nephrotic Syndrome??: Secondary causes (e.g., lupus nephritis, Henoch-Schönlein purpura nephritis). Steroid-resistant nephrotic syndrome (SRNS); 7.Major Organ Dysfunction??: Severe cardiac, hepatic, renal, hematologic, or endocrine diseases; 8.??Comorbid Systemic Disorders??: Other autoimmune diseases, primary immunodeficiency, or active malignancies; 9.Prior Anti-CD38 Therapy??: Previous treatment with anti-CD38 agents (e.g., daratumumab); 10.??Recent Interventions??: Live/attenuated vaccination within ??4 weeks?? prior to first dose. Major surgery (excluding diagnostic procedures) within ??4 weeks??; 11.Hypersensitivity??: Known allergy to monoclonal antibodies or excipients of the investigational drug; 12.??Investigator Discretion??: Any other condition deemed by the investigator to compromise patient safety or trial integrity?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number and incidence of adverse events and serious adverse events during the treatment period;Recurrence-free survival at 6 months and 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of recurrences;Time to first recurrence after enrollment;Proportion of relapse study participants;Renal function (serum creatinine, glomerular filtration rate);Cumulative hormone dosage; | — |
Countries
China
Contacts
Public ContactMao Jianhua
Children's Hospital,Zhejiang University School of Medicine
Outcome results
None listed