FRNS/SDNS, Ripertamab
Conditions
Brief 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).
Interventions
DRUGripertamab
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.
Sponsors
Mao Jianhua
Sinocelltech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse free survival rate | 1 year | Relapse free survival rate at 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence frequency at 6 and 12 months | 1 year | Recurrence frequency within 6 months during the study period. Recurrence frequency within 12 months during the study period. |
| Cumulative corticosteroid dose | 1 year | Total amount of corticosteroids used in 1 year during the study period |
| Median recurrence-free survival | 18 months | From admission day to 18 months |
| B-cell count | 18 months | — |
| The occurrence and severity of adverse events | 18 months | — |
Countries
China
Contacts
CONTACTJianhua Mao, MD
CONTACTXuan Gang, MD
Outcome results
None listed