Study of SG301 Injection for Children Aged 6 to 18 With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome

What this Trial Is About

Researchers are studying children aged 6 to 18 with frequently relapsing or steroid-dependent nephrotic syndrome to evaluate the safety, how the body processes, and the early effects of SG301, an anti-CD38 monoclonal antibody given by subcutaneous injection. This phase 2, open-label study aims to provide important information about SG301s impact on this condition, which requires ongoing steroid treatment. Participants are divided into two age groups 12 to under 18 years old and 6 to under 12 years old. The treatment involves nine doses of SG301 injected under the skin weekly for six weeks, then every two weeks for three doses. Before starting SG301, children receive prednisone to induce remission, with steroid doses gradually reduced over three months. The study includes screening, a 12-week treatment period, and a 40-week follow-up. Throughout the trial, children will be closely monitored with blood tests, urine protein measurements, and evaluations of kidney function. Researchers will track safety by recording treatment-emergent adverse events and measure outcomes like relapse-free survival and relapse frequency over about one year. Additional tests include measuring drug levels, antibodies against SG301, and steroid use. This involvement will last over a year, including treatment and follow-up phases.

A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence