SG301 (anti-CD38) injection for children with frequently relapsing or steroid-dependent nephrotic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase 2 study enrolls children aged 6–18 with steroid-sensitive nephrotic syndrome who have frequent relapses or steroid dependence and are in protein remission after steroid treatment. Recruitment begins with the 12–18 age group and will expand to the 6–12 group after interim safety and pharmacology reviews, with phased data review for each 1–3 participants. Participants receive subcutaneous SG301 at 10 mg/kg with weekly injections for six weeks then every two weeks for three doses (nine total injections) during a 12-week treatment period, followed by a 40-week follow-up. The trial focuses on safety, pharmacokinetics, pharmacodynamics, and preliminary signs of reduced relapse or steroid need.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 6 - 18 years.
2. Steroid-sensitive nephrotic syndrome with frequent relapses (FRNS) or steroid dependence (SDNS).
3. Normal renal function: eGFR≥90 ml/min/1.73m².
4. After steroid treatment, morning urine protein\<1 + or urine protein/creatinine\<0.2 g/g (\<20 mg/mmol) for ≥3 consecutive days.
5. 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.
6. Prothrombin time/INR≤1.5×ULN, unless due to anticoagulation.
7. 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:

1. Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia.
2. Alanine aminotransferase \>2×ULN or total bilirubin\>2×ULN with a sustained increase for 2 weeks.
3. 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.
4. Chronic active infections (e.g., Epstein-Barr Virus, Cytomegalovirus, tuberculosis) that may worsen with steroids/ immunosuppressants.
5. Acute active infection (excluding onychomycosis) requiring systemic antibiotics/antivirals.
6. Secondary nephrotic syndrome (e.g.,immunoglobulin A - associated, lupus nephritis); steroid - resistant nephrotic syndrome (SRNS).
7. Other autoimmune diseases, primary immunodeficiency, or malignancy.
8. Prior anti - cluster of differentiation 38 (CD38) treatment.
9. Live/attenuated vaccine receipt or major surgery (non - diagnostic) within 4 weeks before first dose.

Where it's running

• Children's Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Yanyan Jin, Doctor
• Email: jinyanyanzj@163.com
• Phone: +86 19357612502

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.