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Completed

NCT Number: NCT04494438

Rituximab for Idiopathic Nephrotic Syndrome

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.

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Key information

Conditions

Idiopathic Nephrotic Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Nephrosis, Lipoid Nephrotic Syndrome Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IRCCS Giannina Gaslini Institute

Genova, 16147, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rituximab

Drug

Other names: Mabthera, Anti CD-20 antibodies

Primary outcomes

  1. Three months proteinuria

    Time frame: 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 outcomes

  1. Time-to-relapse mesaure

    Time frame: 12 months

    Risk of relapse of proteinuria and need for recovery of steroids, with survival analysis after withdrawal of steroids.

Sponsors and collaborators

Lead sponsor

Istituto Giannina Gaslini

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 31, 2020
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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