Study of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-16
SponsorMao Jianhua
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ripertamab
- ripertamab
Treatment groups
312 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mao Jianhua
Lead sponsor
The Children's Hospital of Zhejiang University School of Medicine
Sponsor institution
Sinocelltech Ltd.
Collaborator
Source ClinicalTrials.gov