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

Official title

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

Overview

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).

Interventions

• Drug ripertamab
  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.
• Drug ripertamab
  1 dose of 375mg/m2 BSA ripertamab. 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 outcome measures

• Relapse free survival rate [Time frame: 1 year]

Secondary outcome measures (5)

• Recurrence frequency at 6 and 12 months [Time frame: 1 year]
• Cumulative corticosteroid dose [Time frame: 1 year]
• Median recurrence-free survival [Time frame: 18 months]
• B-cell count [Time frame: 18 months]
• The occurrence and severity of adverse events [Time frame: 18 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province 3 — Hangzhou

Identifiers

NCT: NCT07388810 · SCT400-NS-ch

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗