A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence
Recruiting
Phase 2
Interventional Study
Nephrotic Syndrome in Children
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 – 18
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Mao Jianhua · Other
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About This Trial
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.
Trial Locations
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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) f…
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