Status:
TERMINATED
Efficacy of Anti-CD20 Antibodies (Rituximab Biosimilar) in the Treatment of Childhood Steroid-dependent Nephrotic Syndrome
Lead Sponsor:
Istituto Giannina Gaslini
Collaborating Sponsors:
Bambino Gesù Hospital and Research Institute
Conditions:
Nephrotic Syndrome Steroid-Dependent
Eligibility:
All Genders
3-24 years
Phase:
PHASE2
Brief Summary
Anti-CD20 monoclonal antibodies are emerging as the steroid-sparing therapy of choice for nephrotic syndrome. This Randomized Clinical Trial seeks to evaluate whether Rituximab biosimilar maintains d...
Detailed Description
Idiopathic nephrotic syndrome (NS) is characterized by proteinuria and hypoalbuminemia associated with dyslipidemia and hypercoagulability. Oral corticosteroids are the cornerstone of therapy and indu...
Eligibility Criteria
Inclusion
- 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any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject any time without prejudice to his or her future medical care.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
- 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
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04402580
Start Date
July 1 2019
End Date
August 31 2020
Last Update
September 14 2020
Active Locations (1)
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1
IRCCS Istituto Giannina Gaslini
Genova, Italy, 16148