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New treatment option for Nephrotic Syndrome in Children
Official title A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence
ClinicalTrials.gov ID: NCT07087314
What this study is testing
What is SG301 Subcutaneous injection?
SG301 Subcutaneous injection is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for nephrotic syndrome in children.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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).
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.