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.
Study 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
Eligibility
Sex
ALL
Min age
1 Year
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* Newly diagnosed steroid-sensitive nephrotic syndrome (SSNS) according to the 2023 IPNA criteria, who achieved complete remission after steroid induction therapy prior to study entry, defined as UPCR (based on first morning void or 24 h urine sample) \<= 20 mg/mmol (0.2 mg/mg), or negative or trace dipstick on three or more consecutive days.
* An estimated glomerular filtration rate \>= 90 mL/min/ 1.73 m2 at study entry.
* Peripheral blood CD20+ (detected as CD19+) cells \>= 1% of total lymphocytes.
* No use of other immunosuppressants within 3 months prior to study entry, other than steroids for nephrotic syndrome.
Exclusion Criteria:
* Known etiology including congenital nephrotic syndrome, IgA nephropathy, Henoch-Schönlein purpura nephritis, lupus nephritis, or other secondary nephrotic syndromes.
* Patients exhibiting any of the following abnormal clinical laboratory values: leukopenia (white blood cells \<= 3.0 × 10\^9/L), absolute neutrophil count \< 1.5 × 10\^9/L; moderate to severe anemia (hemoglobin \< 9.0 g/dL); thrombocytopenia (platelet count \< 100 × 10\^12/L); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal; positive for any autoimmune markers (ANA, ENA, ANCA, etc.) or decreased complement C3 levels.
* Evidence of the following infections: severe or opportunistic infection within the previous 6 months (active tuberculosis or history of tuberculosis or suspected tuberculosis; chronic active infections such as EBV, CMV; active hepatitis B presentation or history, or hepatitis C or hepatitis B virus carrier; HIV infection; or other active viral infections).
* Receipt of live vaccine within one month prior to study entry.
* History of previous use of biological agents.
* Current examination suggestive of heart failure, severe arrhythmia, angina pectoris (CTCAE Grade 4), or uncontrolled blood pressure.
* Severe diseases of vital organs such as the brain or liver, or suffering from hematological or endocrine system disorders.
* Diagnosis of co-existing autoimmune diseases, primary immunodeficiency, or malignancy.
* History of organ transplantation (excluding cornea and hair transplants).
* Known allergy to methylprednisolone, Zuberitamab injection active ingredients or any excipients, sulfamethoxazole (or a contraindication to this drug due to G6PD deficiency).
* Investigator's judgment that the patient is unsuitable for participation in this study (e.g., patient is highly likely to be lost to follow-up or provide false results, such as alcohol dependence or psychiatric illness).
Primary outcome measure(s)
Relapse-free survival time within 12 months after randomization — From randomization until first relapse or 12 months after randomization, whichever occurs first. Time from randomization to the first confirmed disease relapse during the 12-month follow-up period. Participants without relapse will be censored at the date of the last available assessment. Relapse is defined according to the 2023 International Pediatric Nephrology Association (IPNA) criteria as urine dipstick protein ≥3+ (≥300 mg/dL) or urine protein-to-creatinine ratio (UPCR) ≥200 mg/mmol (≥2 mg/mg) on a spot urine sample for three consecutive days, with or without edema, in a participant who previously achieved complete remission.
Trial sites (9)
Facility
City
Region
Status
Children's Hospital of Fudan University
Shanghai
Shanghai Municipality
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
More Children's Hospital of Fudan University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.