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Zuberitamab in the First Episode of Paediatric Nephrotic Syndrome
Sponsor: Children's Hospital of Fudan University
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
Conditions
Interventions
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.
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