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NCT Number: NCT01268033

Efficacy of Rituximab For the Treatment of Calcineurin Inhibitors Dependent Nephrotic Syndrome During Childhood

Background

Idiopathic nephrotic syndrome is a rare disease beginning during childhood and treated with immunosuppressants (i.e. steroids, mycophenolate mofetil, cyclophosphamide, cyclosporine).

Renal function of patients suffering from severe, steroid-dependent nephrotic syndrome with failure or toxic side effects of other immunosuppressant treatments is a major matter of concern.

Cyclosporine endangers renal parenchyma (fibrosis) in these patients who must take this treatment for years. At the same time, low doses of cyclosporine allow proteinuria to reappear, which provokes degradation of renal function by focal segmental glomerulosclerosis. Some recent data lead to the conclusion that Rituximab may be effective in such a disease, with a cyclosporin sparing effect.

Purpose

The aim of the study is to evaluate the efficacy of Rituximab versus placebo in the treatment of pediatric patients suffering from severe cyclosporine-dependent nephrotic syndrome.

Abstract Patients will be included in the study in a period of remission of proteinuria. Two infusions of Rituximab - at the dose of 375 mg/m²- or placebo will be administered at one week of interval. Other immunosuppressant treatments will be gradually tapered off with the same tapering pattern in both groups. In case of relapse of nephrotic syndrome, the blinding code will be broken. Rituximab will then be infused to patients having received placebo.

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Key information

Conditions

Childhood Idiopathic Nephrotic Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulosclerosis, Focal Segmental Kidney Diseases Male Urogenital Diseases Nephritis Nephrosis Nephrosis, Lipoid Nephrotic Syndrome Urogenital Diseases Urologic Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Queen Fabiola Universitary Children's Hospital, Brussels, Brussels Capital, Belgium

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About this study

After infusions of Rituximab or placebo, patients will be examined by their nephrologist on a monthly basis during five months. Follow up will be focused on proteinuria, albuminemia, lymphocyte phenotyping and Rituximab pharmacokinetics

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or Female patients over 2 and under 18 years, with an idiopathic nephrotic syndrome (NS)
  • Steroid Sensitive Nephrotic Syndrome (according to the French pediatric protocol).

NEPHRUTIX

  • Calcineurin inhibitor Dependent NS or NS for which anticalcineurin treatment has not been effective. Others immunosuppressive treatments (MMF) must have failed to control the disease activity.
  • Effective contraception for girls of childbearing age.
  • The patient is able to understand and has signed a written informed consent OR the parent or legal guardian is able to understand and has signed a written informed consent, which must be obtained prior to the initiation of any study procedure

Exclusion criteria

  • Terminal renal failure requiring dialysis/transplantation
  • Transcutaneous oxygen stauration < 97%
  • Clinical or Radiological brochopulmonar or pleural abnormality
  • Asymptomatic carrier of Hepatitis B virus our history of Hepatitis B
  • Contraindication to Rituximab (RTX)
  • Parents/patient refusing to participate in the study

Treatment and study plan

Rituximab

Drug

two infusions - at the dose of 375 mg/m²- will be administered at one week of interval

Placebo

Drug

two infusions - at the dose of 375 mg/m² - will be administrered at one week of interval

Primary outcomes

  1. Proteinuria with relapse of nephrotic syndrome (Serum albumin < 30 g/L) within 5 months

    Time frame: 5 months

    Proteinuria with relapse of nephrotic syndrome (Serum albumin < 30 g/L) within 5 months

Secondary outcomes

  1. - dosing of rituximab for toxicity during and/or after infusion

    Time frame: 5 months

    • toxicity during and/or after infusion

  2. - dosing of rituximab for pharmacokinetics

    Time frame: 5 months

    • dosing of rituximab for pharmacokinetics

  3. - dosing of lymphocyte

    Time frame: 5 months

    • lymphocyte phenotyping

  4. Pediatric Quality of life inventory

    Time frame: 5 months

    Pediatric Quality of life inventory

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

A Prospective, Randomized, Double Blind, Placebo-controlled Phase II/III Study Evaluating the Efficacy of Rituximab in the Prevention of Relapse of Calcineurin Inhibitors Dependent Idiopathic Nephrotic Syndrome of Childhood

Acronym: NEPHRUTIX

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 29, 2010
Registry last updated
Mar 23, 2015

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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