Not Yet RecruitingNot Applicable

Study of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome

China312 participantsStarted 2026-02

Plain-language summary

This is an open-label randomized controlled trial to evaluate the efficacy and safety of one dose versus two doses of ripertamab in children with frequent relapses or steroid-dependent nephrotic syndrome (FRNS/SDNS).

Who can participate

Age range

1 Year – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 16 years old and above with FRNS/SDNS
. Before enrollment, achieved complete remission (urine protein/creatinine ratio (morning urine or 24-hour urine) ≤ 20mg/mmol (0.2mg/mg) or \< 100mg/m2/d, or test strip result negative or trace)
. Within 2 months before enrollment, did not use levamisole, alkylating agents such as cyclophosphamide, calcineurin inhibitors such as cyclophosphamide and cyclosporine, or mycophenolate mofetil. Within 6 months before enrollment, did not use other CD20 monoclonal antibodies (such as ofatumumab, otuzumab, etc., excluding rituximab)
. Glomerular filtration rate (eGFR) \> 60ml/min/1.73m2
. The patient or their guardian agrees to participate in this clinical trial and signs the informed consent form, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the study

Exclusion criteria

. Known causes (such as systemic lupus erythematosus, IgA nephropathy, other secondary nephrotic syndromes, amyloidosis, malignant tumors, etc.)
. Known active chronic infections, including tuberculosis, HIV, HBV, HCV, etc.
. Severe leukopenia (white blood cells \< 3.0×109/L), severe anemia (hemoglobin \< 8.9 g/dl), thrombocytopenia (platelets \< 100×109/L), or liver dysfunction (alanine aminotransferase/aspartate aminotransferase \> 2 times the upper limit of normal)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Relapse free survival rate

Timeframe: 1 year

Trial details

NCT IDNCT07388810

SponsorMao Jianhua

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Jianhua Mao, MD

13516819071 maojh88@zju.edu.cn

View on ClinicalTrials.gov More FRNS/SDNS trials