Actively Recruiting
A Clinical Study to Evaluate the Initial Efficacy and Safety of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children 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 SG301's 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 12 weeks
Participants receive SG301 Subcutaneous injection with weekly injections for the first six weeks, followed by injections every two weeks for three doses, totaling nine injections over 12 weeks. Prednisone is tapered during this period according to the protocol.
Weekly visits for the first 6 weeks, then visits every two weeks for 6 weeks
Duration - 40 weeks
Participants are monitored for safety, efficacy, and relapse for up to 40 weeks after treatment completion.
Periodic follow-up visits during this period
Trial Site Locations
Total: 1 location
1
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310052
Actively Recruiting
Research Team
Y
Yanyan Jin, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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