Zuberitamab in the First Episode of Paediatric Nephrotic Syndrome

Summary

The goal of this clinical trial is to learn whether adding Zuberitamab to standard corticosteroid therapy can help prevent relapse in children and adolescents aged 1 to 18 years with newly diagnosed steroid-sensitive nephrotic syndrome (SSNS). It will also learn about the safety of Zuberitamab.

The main questions it aims to answer are:

* Does Zuberitamab plus standard corticosteroid therapy prolong the time to first relapse compared with standard corticosteroid therapy alone?
* What medical problems do participants experience during treatment?

Researchers will compare Zuberitamab plus standard corticosteroid therapy to standard corticosteroid therapy alone to see whether adding Zuberitamab improves disease control.

Participants will:

* Receive standard corticosteroid treatment for approximately 12 weeks, with or without a single intravenous infusion of Zuberitamab after achieving remission
* Take preventive antibiotics if they are in the Zuberitamab group
* Test their urine daily at home using dipsticks and record results in a diary
* Visit the clinic for regular checkups and blood and urine tests during follow-up for up to 12 months

Conditions

• Nephrotic Syndrome

Interventions

BIOLOGICAL

Zuberitamab

Zuberitamab is administered as a single intravenous infusion at a dose of 375 mg/m² (maximum 500 mg) following achievement of steroid-sensitive remission. To reduce the risk of infusion-related reactions, premedication is administered approximately 30 minutes before infusion and may include: * Acetaminophen or ibuprofen; * Cetirizine, cyproheptadine, loratadine, or equivalent antihistamines; * Intravenous methylprednisolone 1.6 mg/kg (maximum 48 mg). Participants receiving zuberitamab also receive prophylactic trimethoprim-sulfamethoxazole (TMP 3 mg/kg every other day; maximum SMZ dose 960 mg every other day) until B-cell recovery. Infusion-related reactions are managed according to protocol-defined procedures, including infusion rate reduction, temporary interruption, permanent discontinuation when clinically indicated, and appropriate supportive therapy.

DRUG

standard corticosteroid treatment

standard corticosteroid treatment administered orally to treat steroid-sensitive nephrotic syndrome: 6 weeks at 2 mg/kg (max 60 mg/day), then alternate day steroid 1.5 mg/kg (max 40 mg on alternate days) for 6 weeks.

Sponsors & Collaborators

• Guiyang Maternal and Child Health Care Hospital

  collaborator OTHER

• Wuhan Children's Hospital

  collaborator OTHER

• Shanghai Children's Medical Center

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Shanghai Children's Hospital

  collaborator OTHER

• Wuxi Women's & Children's Hospital

  collaborator OTHER

• Xiamen Maternity & Child Care Hospital

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Children's Hospital of Fudan University

  lead OTHER

Principal Investigators

• Hong Xu · Children's Hospital of Fudan University

• Qian Shen · Children's Hospital of Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-20

Primary Completion

2028-08-20

Completion

2028-12-31

Countries

• China

Study Locations