NCT07087314 A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence
| NCT ID | NCT07087314 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mao Jianhua |
| Condition | Nephrotic Syndrome in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2028-07-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-08-25 with a primary completion date of 2028-07-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 6 - 18 years. 2. Steroid-sensitive nephrotic syndrome with frequent relapses (FRNS) or steroid dependence (SDNS). 3. Normal renal function: eGFR≥90 ml/min/1.73m². 4. After steroid treatment, morning urine protein\<1 + or urine protein/creatinine\<0.2 g/g (\<20 mg/mmol) for ≥3 consecutive days. 5. 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. 6. Prothrombin time/INR≤1.5×ULN, unless due to anticoagulation. 7. 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: 1. Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia. 2. Alanine aminotransferase \>2×ULN or total bilirubin\>2×ULN with a sustained increase for 2 weeks. 3. 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. 4. Chronic active infections (e.g., Epstein-Barr Virus, Cytomegalovirus, tuberculosis) that may worsen with steroids/ immunosuppressants. 5. Acute active infection (excluding onychomycosis) requiring systemic antibiotics/antivirals. 6. Secondary nephrotic syndrome (e.g.,immunoglobulin A - associated, lupus nephritis); steroid - resistant nephrotic syndrome (SRNS). 7. Other autoimmune diseases, primary immunodeficiency, or malignancy. 8. Prior anti - cluster of differentiation 38 (CD38) treatment. 9. Live/attenuated vaccine receipt or major surgery (non - diagnostic) within 4 weeks before first dose.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07087314 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Nephrotic Syndrome in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07087314 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07087314 currently recruiting?
Yes, NCT07087314 is actively recruiting participants. Contact the research team at jinyanyanzj@163.com for enrollment information.
Where is the NCT07087314 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07087314 clinical trial?
NCT07087314 is sponsored by Mao Jianhua. The trial plans to enroll 30 participants.