One infusion may keep childhood kidney disease at bay — a trial puts it to the test
NCT ID NCT07765914
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This trial tests whether adding a single infusion of zuberitamab to standard steroid therapy can help children aged 1 to 18 with newly diagnosed steroid-sensitive nephrotic syndrome stay relapse-free longer. Participants receive either standard steroids alone or steroids plus zuberitamab, and are followed for up to 12 months with daily urine tests and regular checkups. The study aims to see if the extra treatment improves disease control and to assess its safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zuberitamab (a biologic given as a single intravenous infusion)
- What this could lead to
- If it works, adding zuberitamab to standard steroids could help children with nephrotic syndrome avoid relapses and reduce the need for repeated steroid courses.
- What could go wrong
- This is an early-phase trial with a limited number of participants, so results may not apply to all children. Zuberitamab can cause infusion reactions and may increase infection risk, requiring preventive antibiotics.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
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Guiyang Maternal and Child Health Care Hospital
Guiyang, China
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Second Xiangya Hospital of Central South University
Changsha, China
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Shanghai Children's Hospital
Shanghai, China
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Shanghai Children's Medical Center
Shanghai, China
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Wuhan Children's Hospital
Wuhan, China
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Wuxi Women's & Children's Hospital
Wuxi, China
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Xiamen Maternity & Child Care Hospital
Xiamen, China
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- China launches massive kidney registry to map nephrotic syndrome
- Kidney disease drug may train immune cells to calm themselves
- A new tool to predict kidney failure risk in membranous nephropathy?
- Kidney disease biobank aims to unlock new treatments
- Scientists hunt for genes behind kidney disease
- Could less steroid be just as good for kids with kidney disease?