Actively Recruiting
Study of SG301 Injection for Children Aged 6 to 18 With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome
Led by Mao Jianhua · Updated on 2026-02-27
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying children aged 6 to 18 with frequently relapsing or steroid-dependent nephrotic syndrome to evaluate the safety, how the body processes, and the early effects of SG301, an anti-CD38 monoclonal antibody given by subcutaneous injection. This phase 2, open-label study aims to provide important information about SG301s impact on this condition, which requires ongoing steroid treatment. Participants are divided into two age groups 12 to under 18 years old and 6 to under 12 years old. The treatment involves nine doses of SG301 injected under the skin weekly for six weeks, then every two weeks for three doses. Before starting SG301, children receive prednisone to induce remission, with steroid doses gradually reduced over three months. The study includes screening, a 12-week treatment period, and a 40-week follow-up. Throughout the trial, children will be closely monitored with blood tests, urine protein measurements, and evaluations of kidney function. Researchers will track safety by recording treatment-emergent adverse events and measure outcomes like relapse-free survival and relapse frequency over about one year. Additional tests include measuring drug levels, antibodies against SG301, and steroid use. This involvement will last over a year, including treatment and follow-up phases.
CONDITIONS
Brief Title
A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 6 to 18 years
- Steroid-sensitive nephrotic syndrome with frequent relapses or steroid dependence
- Normal kidney function with eGFR of 90 ml/min/1.73m² or higher
- Morning urine protein less than 1+ or urine protein/creatinine less than 0.2 g/g for at least 3 consecutive days after steroid treatment
- Blood tests within 7 days before enrollment showing hemoglobin above 80 g/L, platelets above 75 x10⁹/L, and neutrophils above 1.5 x10⁹/L
- Prothrombin time/INR less than or equal to 1.5 times the upper limit of normal, unless due to anticoagulation
- No use of certain immunosuppressive drugs (Tacrolimus, cyclosporine A, mycophenolate mofetil, belimumab, levamisole, azathioprine, cyclophosphamide) in prior 2 months; no rituximab or obinutuzumab in prior 6 months
You will not qualify if you...
- Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia
- Alanine aminotransferase or total bilirubin more than twice the upper limit of normal for at least 2 weeks
- Positive Hepatitis B surface antigen or core antibody with elevated Hepatitis B virus DNA; positive Hepatitis C antibody with RNA positive; or positive HIV antibody
- Chronic active infections that may worsen with steroids or immunosuppressants, such as Epstein-Barr Virus, Cytomegalovirus, or tuberculosis
- Acute active infection requiring systemic antibiotics or antivirals (excluding onychomycosis)
- Secondary nephrotic syndrome or steroid-resistant nephrotic syndrome
- Other autoimmune diseases, primary immunodeficiency, or cancer
- Previous treatment with anti-CD38 therapy
- Receipt of live or attenuated vaccines or major non-diagnostic surgery within 4 weeks before first dose
Research Team
Y
Yanyan Jin, Doctor
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