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Phase 3
Age: 2Years - 18Years
All Genders
ID06125405

Evaluating Weekly Telitacicept Treatment for Children Ages 2 to 18 With Frequent Relapse or Steroid-Dependent Nephrotic Syndrome Over One Year

Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2024-08-21

20

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying telitacicept in children aged 2 to 18 years with frequently relapsing or steroid-dependent nephrotic syndrome, a common kidney disease in children that can be hard to treat. This condition often requires long-term steroid use which can cause serious side effects. The study aims to find out if telitacicept can offer better results and safety compared to existing treatments, addressing a significant need for improved options in this condition. Participants will receive weekly subcutaneous injections of telitacicept for 52 weeks. The dose varies based on body weight, ranging from 40mg to 160mg per week. This is an open-label trial where all enrolled children will be treated with telitacicept to assess its effects over one year. During the study, children will be closely monitored through regular tests including urine protein levels, kidney function, blood tests, and body mass index measurements. Researchers will track relapse rates over 12 months and measure how long it takes for the first relapse to occur. Safety and changes in health markers like hemoglobin and albumin levels will also be evaluated to understand the impact of the treatment over the year-long study period.

CONDITIONS

Brief Title

Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome

Research Team

J

Jianhua Mao, MD

C

Chunyue Feng

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