NCT07388810

Study of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome

Study of Different Doses of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome：An Open-label Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Mao Jianhua · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

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).

Conditions

• FRNS/SDNS
• Ripertamab

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-01
• Completion: 2028-02-01
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: China