Status:
COMPLETED
Rituximab for Idiopathic Nephrotic Syndrome
Lead Sponsor:
Istituto Giannina Gaslini
Conditions:
Idiopathic Nephrotic Syndrome
Eligibility:
All Genders
1-16 years
Phase:
PHASE3
Brief Summary
Open-label, randomized, controlled trial due to value whether the monoclonal antibody rituximab is non-inferior to steroids in maintaining remission in juvenile forms of SDNS. The investigators will ...
Eligibility Criteria
Inclusion
- Age between 1 and 16 years.
- Steroid-dependent idiopatic nephrotic syndrome for a minimum of 6 to a maximum of 12 months at the time of study entry, regardless of disease duration.
- Low-dose steroid dependence (between 0.4 and 0.7 mg/ kg/ day)
Exclusion
- Positivity of autoimmunity tests (ANA, nDNA, ANCA) or reduced C3 levels
- Histological pattern suggestive for congenital anomalies (diffuse mesangial sclerosis without IgM deposits, cystic-like tubular dilations, evidence of mithocondrial damage on electronic microscopy.
- Histological pattern not correlated with idiopathic nephrotic syndrome in the pediatric age (membranous glomerulonephritis, lupus nephritis, diffuse and/or localized vasculitis, amyloidosis).
- Evidence of homozygous or heterozygous mutations in podocitary genes commonly involved in the pathology (NPHS1, NPHS2, WT1).
- Estimated glomerula filtration rate (eGFR) \< 60ml/min.
- Presence of circulating IgM against HCV, HBV, parvovirus or mycoplasm.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04494438
Start Date
July 1 2013
End Date
December 1 2016
Last Update
January 4 2023
Active Locations (1)
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1
IRCCS Giannina Gaslini Institute
Genova, Italy, 16147