Zuberitamab in the First Episode of Paediatric Nephrotic Syndrome
ConditionNephrotic Syndrome
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-18
SponsorChildren's Hospital of Fudan University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Zuberitamab
Biological/VaccineZuberitamab 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
Drugstandard 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Zuberitamab + Standard corticosteroid treatmentExperimental treatment 2 interventions
Group B: Standard corticosteroid treatment OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Relapse-free survival time within 12 months after randomization
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.
Time frame
From randomization until first relapse or 12 months after randomization, whichever occurs first.Secondary outcomes
1
Relapse-Free Survival Rate at 12 Months Post-Randomization
The proportion of participants who remain free from disease relapse at 12 months after randomization.
Time frame
12 months post-randomization.2
Relapse-Free Survival Rate at 6 Months Post-Randomization
The proportion of participants who remain free from disease relapse at 6 months after randomization.
Time frame
6 months post-randomization.3
Cumulative Steroid Dose at 12 Months Post-Randomization
The total amount of steroid medication (prednisolone) taken by participants from randomization until 12 months.
Time frame
12 months post-randomization.4
Change From Baseline in Serum Creatinine (Renal Function) at 12 Months
Change from baseline in serum creatinine levels to assess renal function.
Time frame
From baseline to 12 months post-randomization.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Fudan University
Lead sponsor
Guiyang Maternal and Child Health Care Hospital
Collaborator
Wuhan Children's Hospital
Collaborator
Shanghai Children's Medical Center
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Shanghai Children's Hospital
Collaborator
Wuxi Women's & Children's Hospital
Collaborator
Xiamen Maternity & Child Care Hospital
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
Source ClinicalTrials.gov
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