Rituximab for Idiopathic Nephrotic Syndrome

Istituto Giannina Gaslini

Status and phase: Completed; Phase 3

Conditions: Idiopathic Nephrotic Syndrome

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT04494438

IGG-SN-MAB2 Low Dose

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Steroid tapering.

No Intervention group

Rituximab

Experimental group

Description:

Single administration of Rituximab 375 mg/mq at a rate of 0.5 to 1.5 ml/min over approximately 6 hours, following the infusion of 2.5-5 mg of intravenous chlorfenamine maleate (based on the local protocol and patient tolerance), methylprednisolone (2 mg/Kg) in normal saline and oral paracetamol (8 mg/kg).

Treatment:

Drug: Rituximab