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Not yet recruitingPhase 3

Zuberitamab added to steroid treatment for first episode of nephrotic syndrome in children

Tests Zuberitamab with steroids in children newly diagnosed with steroid-sensitive nephrotic syndrome.

Key facts

Who runs it
Children's Hospital of Fudan University
Where
China9 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Zuberitamab in the First Episode of Paediatric Nephrotic Syndrome
Status
Not yet recruiting
Phase
Phase 3
People taking part
120 people, planned
Started
20 Aug 2026
Expected to end
31 Dec 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Zuberitamab
  • standard corticosteroid treatment
Record updated
14 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with a first episode of steroid-sensitive nephrotic syndrome, a kidney condition. They must already be in full remission after steroid treatment.

Age
1 Year to 18 Years
Sex
All sexes can join.
Disease stage
Newly diagnosed steroid-sensitive nephrotic syndrome by the 2023 IPNA criteria. Complete remission after steroid treatment before entry: UPCR <= 20 mg/mmol (0.2 mg/mg), or negative or trace urine dipstick on three or more days in a row. Kidney filtration rate (eGFR) >= 90 mL/min/ 1.73 m2.
Earlier treatment
Must have had steroid treatment that brought remission. No other immune-suppressing drugs within 3 months before entry, other than steroids. No earlier use of biological agents. No live vaccine within one month before entry.
Biomarker or test result
Blood CD20+ (measured as CD19+) cells >= 1% of total lymphocytes.

Main reasons for not taking part

  • Nephrotic syndrome with a known cause, such as congenital, IgA nephropathy, lupus nephritis or other secondary forms.
  • Low blood counts, raised liver tests, positive autoimmune markers or low complement C3.
  • Serious or chronic infections, including tuberculosis, hepatitis B or C, EBV, CMV or HIV.
  • Heart failure, severe heart rhythm problems, uncontrolled blood pressure, or severe brain, liver, blood or hormone disorders.
  • Autoimmune disease, immune deficiency, cancer, organ transplant, or allergy to the study drugs or sulfamethoxazole.

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Known etiology including congenital nephrotic syndrome, IgA nephropathy, Henoch-Schönlein purpura nephritis, lupus nephritis, or other secondary nephrotic syndromes
  • 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)
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 1 and 18 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 2 groups in the trial

  • Zuberitamab + Standard corticosteroid treatmentTreatment being tested

    Zuberitamab plus standard corticosteroid treatment: Zuberitamab 375 mg/m2 (max 500 mg) as a single IV dose after remission. Premedication 30 min prior includes oral antipyretic and antihistamine and IV methylprednisolone 1.6 mg/kg (max 48 mg); oral steroid withheld on infusion day. Standard corticosteroid treatment consists of oral prednisone/prednisolone per protocol taper. TMP-SMZ prophylaxis (TMP 3 mg/kg on alternate days, max SMZ 960 mg) is administered until CD19 recovery. Relapse is managed per protocol with corticosteroid re-induction and possible repeat zuberitamab after remission. Permitted and prohibited concomitant medications are the same as in the comparator arm.

    Treatment: Zuberitamab and standard corticosteroid treatment

  • Standard corticosteroid treatment OnlyExisting treatment, for comparison

    Standard corticosteroid treatment: oral prednisone/prednisolone 2 mg/kg/day (max 60 mg) for 6 weeks, followed by 1.5 mg/kg (max 40 mg) on alternate days for 6 weeks, then discontinue. No zuberitamab, TMP-SMZ prophylaxis, or infusion premedication is given during initial treatment. Relapse is managed per protocol with corticosteroid re-induction; participants may receive zuberitamab after remission is re-achieved according to predefined criteria. Permitted concomitant medications include antihypertensives, calcium supplementation, anti-infective agents, antihistamines, anticoagulants, IVIG, hepatoprotective agents, glucose-lowering medications, and ophthalmic treatments. Prohibited therapies include other immunosuppressants (rituximab, CNIs, MMF, cyclophosphamide, plasma exchange) and Chinese herbal medicines for nephrotic syndrome (e.g., Huangkui, Huaiqihuang, Tripterygium). Live vaccines are prohibited during B-cell depletion.

    Treatment: standard corticosteroid treatment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy and Safety of Single-dose Zuberitamab in the Initial Episode of Paediatric Steroid-sensitive Nephrotic Syndrome: A Multicenter Randomized Controlled Trial
Plain-language title
Zuberitamab added to steroid treatment for first episode of nephrotic syndrome in childrenGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Fit questions
Built from NCT07765914, who can take part
Record updated
14 August 2026