Rituximab for Idiopathic Nephrotic Syndrome

Rituximab in Patients With Low Dose Steroid-dependent Idiopathic Nephrotic Syndrome

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04494438

Enrollment

Registered

2020-07-31

Start date

2013-07-31

Completion date

2016-12-31

Last updated

2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Nephrotic Syndrome

Keywords

Nephrotic syndrome, Proteinuria, Rituximab

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 enroll 30 pediatric patients affected by idiopathic nephrotic syndrome, who have been in treatment with steroids for at least one year. The lowest dose of drug required to maintain a stable remission will be between 0.4 and 0.7 mg/ kg/ day. This trial provides an initial run-in phase of one month during wich remission will be achieved by means of a standard oral prednisone course. Once remission has been achieved children will be randomized in a parallel arm open label RCT to continue prednisone alone for one month (control) or to add a single intravenous infusion of rituximab (375 mg/m2 - intervention). Prednisone will be tapered in both arms after one month.

Interventions

DRUGRituximab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 16 Years

Healthy volunteers

Inclusion criteria

* 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 criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Three months proteinuria	3 months	To be considered non-inferior, rituximab will have to allow steroid withdrawal and maintain three-month proteinuria within a pre-specified non-inferiority margin of three times the levels among controls.

Secondary

Measure	Time frame	Description
Time-to-relapse mesaure	12 months	Risk of relapse of proteinuria and need for recovery of steroids, with survival analysis after withdrawal of steroids.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026