Actively Recruiting
Study of Blinatumomab Treatment for Children Ages 2 to 17 with Steroid-Resistant Nephrotic Syndrome Resistant or Intolerant to Calcineurin Inhibitors
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2025-08-06
6
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of Blinatumomab in children aged 2 to 17 years who have a difficult-to-treat form of steroid-resistant nephrotic syndrome SRNS. These children either do not respond to calcineurin inhibitors CNIs or are resistant to multiple immunosuppressive treatments, including biologics. SRNS is characterized by heavy protein loss in urine and is linked to poor outcomes with limited treatment options. Participants will receive two short courses of low-dose Blinatumomab administered intravenously. Each course lasts 5 days, with the second course starting three weeks after the first. This open-label, single-arm study will enroll six children to assess whether this treatment can reduce proteinuria and induce remission by targeting specific immune cells. Throughout the study, researchers will monitor protein levels in urine, kidney function, safety, and immune markers over 24 to 52 weeks. Participants will undergo clinical assessments and laboratory tests to evaluate treatment effects and side effects. The study aims to gather preliminary data on Blinatumomab as a potential new therapy for children with resistant SRNS.
CONDITIONS
Brief Title
Blinatumomab for CNI-Resistant/Intolerant SRNS in Children
Research Team
J
Jianhua Mao, PhD, MD
X
Xiaojing Zhang, MD
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