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NOT YET RECRUITING
NCT07388810
NA

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

Sponsor: Mao Jianhua

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province 310052

Hangzhou, Zhejiang, China