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Study of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome
Sponsor: Mao Jianhua
Summary
This is an open-label randomized controlled trial to evaluate the efficacy and safety of one dose versus two doses of ripertamab in children with frequent relapses or steroid-dependent nephrotic syndrome (FRNS/SDNS).
Official title: Study of Different Doses of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome:An Open-label Randomized Controlled Trial
Key Details
Gender
All
Age Range
1 Year - 16 Years
Study Type
INTERVENTIONAL
Enrollment
312
Start Date
2026-02
Completion Date
2028-02
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
ripertamab
2 doses of 375mg/m2 BSA ripertamab at 1-week intervals( within ±1days). At the meantime, prednisone is administered at a dose of 1.5 mg/kg/d (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg/kg every 2 weeks, and the drug is discontinued at 3 months.
ripertamab
1 dose of 375mg/m2 BSA ripertamab. At the meantime, prednisone is administered at a dose of 1.5 mg/kg/d (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg/kg every 2 weeks, and the drug is discontinued at 3 months.
Locations (1)
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province 310052
Hangzhou, Zhejiang, China