Actively Recruiting
A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence
Led by Mao Jianhua · Updated on 2026-02-27
30
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 ≥ 90 ml/min/1.73m²
- Morning urine protein < 1+ or urine protein/creatinine < 0.2 g/g for at least 3 consecutive days after steroid treatment
- Blood tests within 7 days before enrollment showing hemoglobin > 80 g/L, platelets > 75×10⁹/L, neutrophils > 1.5×10⁹/L without growth factors or transfusions
- Prothrombin time/INR ≤ 1.5× upper limit of normal unless due to anticoagulation
- No use of Tacrolimus, cyclosporine A, mycophenolate mofetil, belimumab, levamisole, azathioprine, or cyclophosphamide in the previous 2 months
- No use of rituximab or obinutuzumab in the previous 6 months
You will not qualify if you...
- Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia
- Alanine aminotransferase > 2× upper limit of normal or total bilirubin > 2× upper limit of normal sustained for 2 weeks
- Positive tests for Hepatitis B surface antigen or core antibody with high Hepatitis B DNA, Hepatitis C antibody with positive RNA, or HIV antibody
- Chronic active infections such as Epstein-Barr Virus, Cytomegalovirus, or tuberculosis that could worsen with steroids or immunosuppressants
- Acute active infections requiring systemic antibiotics or antivirals (excluding onychomycosis)
- Secondary nephrotic syndrome or steroid-resistant nephrotic syndrome
- Other autoimmune diseases, primary immunodeficiency, or malignancy
- Prior treatment with anti-CD38 therapies
- Receipt of live or attenuated vaccines or major non-diagnostic surgery within 4 weeks before first dose
AI-Screening
AI-Powered Screening
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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
CONTACT
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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