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One infusion may keep childhood kidney disease at bay — a trial puts it to the test

NCT ID NCT07765914

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

1 year to 18 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, China

  • Guiyang Maternal and Child Health Care Hospital

    Guiyang, China

  • Second Xiangya Hospital of Central South University

    Changsha, China

  • Shanghai Children's Hospital

    Shanghai, China

  • Shanghai Children's Medical Center

    Shanghai, China

  • Wuhan Children's Hospital

    Wuhan, China

  • Wuxi Women's & Children's Hospital

    Wuxi, China

  • Xiamen Maternity & Child Care Hospital

    Xiamen, China

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, China

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