A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SG301 Subcutaneous injection.
- Who it may be relevant to
- Registry conditions: Nephrotic Syndrome in Children. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
This study will recruit children aged 6 - 18 with frequently relapsing or steroid - dependent nephrotic syndrome, who have morning urine protein \< 1 + or urine protein / creatinine \< 0.2 g/g (\<20 mg/mmol) for at least three consecutive days after steroid treatment.
The study will stratify participants into two age groups:≥6 - \<12 years and≥12 - \<18 years. Recruitment will start with the 12 - 18 - year - old group. After collecting sufficient safety and clinical pharmacology data to support moving to lower age groups, the 6 - 12 - year - old group will be recruited. For every 1 to 3 participants enrolled, there will be a phased data review to guide further recruitment.
The trial has three phases: screening (D - 28\~D - 1), treatment (12 - week), and follow - up (40 - week). The enrolled participants will be treated with 10 mg/kg SG301 Subcutaneous injection subcutaneously. They will receive weekly injections for the first six weeks, then every two weeks for three times, totaling nine injections.
Interventions
- Drug SG301 Subcutaneous injection
Subcutaneous injection every weeks (QW\*6),subsequently, administer it once every two weeks for a total of three times (Q2W\*3). The total number of doses is nine.
Primary outcome measures
- Incidence and rate of treatment-Emergent Adverse Events [Time frame: From baseline through study completion, an average of 1 year]
- Relapse free survival rate [Time frame: Average 1 year per subject]
Secondary outcome measures (8)
- Relapse frequency in times [Time frame: From baseline through study completion, an average of 1 year]
- Time to Relapse [Time frame: From baseline through study completion, an average of 1 year]
- Serum creatinine [Time frame: From baseline through study completion, an average of 1 year]
- estimated glomerular filtration rate [Time frame: From baseline through study completion, an average of 1 year]
- Cumulative corticosteroid dose [Time frame: From baseline through study completion, an average of 1 year]
- SG301 anti-drug antibodies [Time frame: From baseline through study completion, an average of 1 year]
- Neutralizing antibodies against SG301 [Time frame: From baseline through study completion, an average of 1 year]
- pharmacokinetics : Ctrough [Time frame: From baseline through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Children's Hospital, Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07087314 · CSG-301 SC-204