A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephroti… (NCT07087314) | Clinical Trial Compass
RecruitingPhase 2
A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence
China30 participantsStarted 2025-08-25
Plain-language summary
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.
Who can participate
Age range6 Years – 18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Within 7 days before enrollment, blood tests (without growth factors or transfusions) must meet: hemoglobin\>80 g/L; platelets\>75×10⁹/L; neutrophils\>1.5×10⁹/L.
✓. Prothrombin time/INR≤1.5×ULN, unless due to anticoagulation.
✓. No Tacrolimus, cyclosporine A, mycophenolate mofetil, belimumab, levamisole, azathioprine, or cyclophosphamide in prior 2 months; no rituximab or obinutuzumab in prior 6 months.
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence and rate of treatment-Emergent Adverse Events
Timeframe: From baseline through study completion, an average of 1 year