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NCT Number: NCT07388810

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

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).

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Key information

Conditions

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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

Treatment and study plan

ripertamab

Drug

2 doses of 375mg/m2 BSA ripertamab at 1-week intervals( within ±1days). At the meantime, prednisone is administered at a dose of 1.5 mg/kg/d (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg/kg every 2 weeks, and the drug is discontinued at 3 months.

Primary outcomes

  1. Relapse free survival rate

    Time frame: 1 year

    Relapse free survival rate at 1 year

Secondary outcomes

  1. Recurrence frequency at 6 and 12 months

    Time frame: 1 year

    Recurrence frequency within 6 months during the study period. Recurrence frequency within 12 months during the study period.

  2. Cumulative corticosteroid dose

    Time frame: 1 year

    Total amount of corticosteroids used in 1 year during the study period

  3. Median recurrence-free survival

    Time frame: 18 months

    From admission day to 18 months

  4. B-cell count

    Time frame: 18 months

  5. The occurrence and severity of adverse events

    Time frame: 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jianhua Mao, MD

CONTACT

[email protected]

13516819071

Xuan Gang, MD

CONTACT

[email protected]

15168358586

Sponsors and collaborators

Lead sponsor

Mao Jianhua

Other

Collaborators

  • Sinocelltech Ltd.

Registry information

Official study title

Study of Different Doses of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome:An Open-label Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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