A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence

Recruiting now · Phase 2

Conditions studied: Nephrotic Syndrome in Children

In brief

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.

Key facts

Study ID

NCT07087314

Run by

Mao Jianhua

People needed

30

Starts

2025-08-25

Expected to finish

2029-07-09

Last updated by the study team

2026-02-27

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Acute active infection (excluding onychomycosis) requiring systemic antibiotics/antivirals.
• Secondary nephrotic syndrome (e.g.,immunoglobulin A - associated, lupus nephritis); steroid - resistant nephrotic syndrome (SRNS).
• Other autoimmune diseases, primary immunodeficiency, or malignancy.
• Prior anti - cluster of differentiation 38 (CD38) treatment.
• Live/attenuated vaccine receipt or major surgery (non - diagnostic) within 4 weeks before first dose.

Where it is running

• Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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