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A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence
Sponsor: Mao Jianhua
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.
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
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-08-25
Completion Date
2029-07-09
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China