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New shot could help kids with kidney disease avoid steroids

NCT ID NCT07087314

Disease control Sponsor: Mao Jianhua Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called SG301 in 30 children aged 6-18 who have nephrotic syndrome that keeps coming back or requires long-term steroids. The drug is given as a shot under the skin and aims to reduce relapses. Researchers will check safety and how well it works over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SG301 (anti-CD38 monoclonal antibody)
What this could lead to
If successful, this could offer a new treatment option to reduce relapses and steroid dependence in children with nephrotic syndrome.
What could go wrong
This is an early Phase 2 study with only 30 children, so results may not apply broadly. Side effects from the antibody are possible, and it may not work better than existing treatments.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

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

Started

Aug 2025

Expected to finish

Jul 2029

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

6 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: 1. Aged 6 - 18 years. 2. Steroid-sensitive nephrotic syndrome with frequent relapses (FRNS) or steroid dependence (SDNS). 3. Normal renal function: eGFR≥90 ml/min/1.73m². 4. After steroid treatment, morning urine protein\<1 + or urine protein/creatinine\<0.2 g/g (\<20 mg/mmol) for ≥3 consecutive days. 5. Within 7 days before enrollment, blood tests (without growth factors or transfusions) must meet: hemoglobin\>80 g/L; platelets\>75×10⁹/L; neutrophils\>1.5×10⁹/L. 6. Prothrombin time/INR≤1.5×ULN, unless due to anticoagulation. 7. No Tacrolimus, cyclosporine A, mycophenolate mofetil, belimumab, levamisole, azathioprine, or cyclophosphamide in prior 2 months; no rituximab or obinutuzumab in prior 6 months. Exclusion Criteria: 1. Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia. 2. Alanine aminotransferase \>2×ULN or total bilirubin\>2×ULN with a sustained increase for 2 weeks. 3. HBsAg or HBcAb positive with Hepatitis B virus DNA above the lower limit of normal; Hepatitis C virus antibody - positive with Hepatitis C virus RNA positive; HIV antibody - positive. 4. Chronic active infections (e.g., Epstein-Barr Virus, Cytomegalovirus, tuberculosis) that may worsen with steroids/ immunosuppressants. 5. Acute active infection (excluding onychomycosis) requiring systemic antibiotics/antivirals. 6. Secondary nephrotic syndrome (e.g.,immunoglobulin A - associated, lupus nephritis); steroid - resistant nephrotic syndrome (SRNS). 7. Other autoimmune diseases, primary immunodeficiency, or malignancy. 8. Prior anti - cluster of differentiation 38 (CD38) treatment. 9. Live/attenuated vaccine receipt or major surgery (non - diagnostic) within 4 weeks before first dose.

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Conditions

The condition(s) this trial relates to.

nephrotic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nephrotic syndrome in children

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310052, China

More trials for these conditions

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