Efficacy of Anti-CD20 Antibodies (Rituximab Biosimilar) in the Treatment of Childhood Steroid-dependent Nephrotic Syndrome
Nephrotic Syndrome Steroid-Dependent
About this trial
This is an interventional treatment trial for Nephrotic Syndrome Steroid-Dependent focused on measuring nephrotic syndrome treatment, rituximab, Mycophenolate Mofetil
Eligibility Criteria
Inclusion Criteria:
To be eligible for inclusion into this study, participants will have to fulfil the following criteria:
- Age between 3 and 24 years
- Prednison dependent steroid syndrome 0.3-1mg/Kg/day and receive prednisone for at least six months before enrolment. Steroid dependence is defined by two consecutive relapse during corticosteroid therapy or within 14 days of ceasing therapy.
- Ability to provide consent and assent: parents'/guardian's written informed consent, and child's assent given before any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject any time without prejudice to his or her future medical care.
Exclusion Criteria:
Children will be excluded if any of the following criteria apply:
- Positivity to autoimmunity tests (ANA, nDNA, ANCA)
- Reduction of C3 levels.
- eGFR<90/ml/min/1,73 m2 valuated according to revised Bedside Schwartz Formula for patients between 2 and 17 years and with CKD-EPI Creatinine 2009 Equation for 18 years old patients.
- Pregnancy
- Neoplasm
- Infections: previous or actual HBV (with HBeAb positivity) or HCV infection
- CD20 B lymphocytes count <2,5%
- Treatment with Rituximab or cyclophosphamide in the last 6 months
Sites / Locations
- IRCCS Istituto Giannina Gaslini
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Rituximab biosimilar
Mycophenolate Mofetil
Drug Name: Rituximab biosimilar monoclonal anti-CD20 antibody Why: Anti-body/antigen interaction results in cell apoptosis and reduced CD20 positive cell related activities (of note CD20 is mostly represented on B cells but also in Th17 cells) How: RTX IV: for dosage between 100 and 250 mg Rituximab will be diluted in 100 ml of normal saline and administered at 2 ml/h for the first 30'; 3 ml/h for the second 30'; 6 ml/h for the third 30'; 15 ml/h until the end. For dosage between 260 and 500 mg Rituximab will be diluted in 250 ml of normal saline and administered at 6 ml/h for the first 30'; 9 ml/h for the second 30'; 18 ml/h for the third 30'; 36 ml/h until the end. For dosage between 510 and 1000 mg Rituximab will be diluted in 500 ml of normal saline and administered at 9 ml/h for the first 30'; thereafter, the infusion rate can be doubled every 30 minutes up to a maximum of 72 ml/h. Where: in Hospital When and how much: once; diluted in 1000 ml of normal saline.
Drug Name: Mycophenolate Mofetil (MMF) Why: selective and reversible inhibition of inosine monophosphate dehydrogenase with inhibition that particularly affects lymphocytes since they rely almost exclusively de novo purine synthesis Procedures: MMF 1,200 mg/1,73 sqm orally divided in 2 daily doses