Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07765914
PHASE3

Zuberitamab in the First Episode of Paediatric Nephrotic Syndrome

Sponsor: Children's Hospital of Fudan University

View on ClinicalTrials.gov

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

Official title: Efficacy and Safety of Single-dose Zuberitamab in the Initial Episode of Paediatric Steroid-sensitive Nephrotic Syndrome: A Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-08-20

Completion Date

2028-12-31

Last Updated

2026-08-14

Healthy Volunteers

No

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.

Locations (9)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Second Xiangya Hospital of Central South University

Changsha, China

Guiyang Maternal and Child Health Care Hospital

Guiyang, China

Shanghai Children's Hospital

Shanghai, China

Shanghai Children's Medical Center

Shanghai, China

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Wuhan Children's Hospital

Wuhan, China

Wuxi Women's & Children's Hospital

Wuxi, China

Xiamen Maternity & Child Care Hospital

Xiamen, China