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

Starting soon · Not applicable

Conditions studied: FRNS/SDNS, Ripertamab

In brief

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).

Key facts

Study ID

NCT07388810

Run by

Mao Jianhua

People needed

312

Starts

2026-02-01

Expected to finish

2028-02-01

Last updated by the study team

2026-02-05

Who can join

Age: 1 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• Received live vaccines within 1 month prior to screening
• Currently participating in other drug clinical trials
• Other conditions that the investigator deems make the patient unsuitable for this study

Where it is running

• Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province 310052 — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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