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

Mao Jianhua

Status: Not yet enrolling

Conditions: Ripertamab; FRNS/SDNS

Treatments: Drug: ripertamab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07388810

SCT400-NS-ch

Details and patient eligibility

About

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).

Enrollment: 312 estimated patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 16 years old and above with FRNS/SDNS
2. 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)
3. 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)
4. Glomerular filtration rate (eGFR) > 60ml/min/1.73m2
5. 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

1. Known causes (such as systemic lupus erythematosus, IgA nephropathy, other secondary nephrotic syndromes, amyloidosis, malignant tumors, etc.)
2. Known active chronic infections, including tuberculosis, HIV, HBV, HCV, etc.
3. 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)
4. Received live vaccines within 1 month prior to screening
5. Currently participating in other drug clinical trials
6. Other conditions that the investigator deems make the patient unsuitable for this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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312 participants in 2 patient groups

Two doses group

Experimental group

Description:

2 doses of 375mg/m2 BSA ripertamab at 1-week intervals( within ±1days).

Treatment:

Drug: ripertamab

Drug: ripertamab

One dose group

Active Comparator group

Description:

1 dose of 375mg/m2 BSA ripertamab.

Treatment:

Drug: ripertamab

Drug: ripertamab