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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01268033
First received: December 15, 2010
Last updated: October 31, 2013
Last verified: October 2012

December 15, 2010
October 31, 2013
December 2010
March 2014   (final data collection date for primary outcome measure)
Proteinuria with relapse of nephrotic syndrome (Serum albumin < 30 g/L) within 5 months [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Proteinuria with relapse of nephrotic syndrome (Serum albumin < 30 g/L) within 5 months
Same as current
Complete list of historical versions of study NCT01268033 on ClinicalTrials.gov Archive Site
  • - dosing of rituximab for toxicity during and/or after infusion [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    - toxicity during and/or after infusion
  • - dosing of rituximab for pharmacokinetics [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    - dosing of rituximab for pharmacokinetics
  • - dosing of lymphocyte [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    - lymphocyte phenotyping
  • Pediatric Quality of life inventory [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Pediatric Quality of life inventory
Same as current
Not Provided
Not Provided
 
Efficacy of Rituximab For the Treatment of Calcineurin Inhibitors Dependent Nephrotic Syndrome During Childhood
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

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.

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Childhood Idiopathic Nephrotic Syndrome
  • Drug: Rituximab
    two infusions - at the dose of 375 mg/m²- will be administered at one week of interval
  • Drug: Placebo
    two infusions - at the dose of 375 mg/m² - will be administrered at one week of interval
  • Experimental: Rituximab
    two infusions of Rituximab - at the dose of 375 mg/m²
    Intervention: Drug: Rituximab
  • Placebo Comparator: placebo
    two infusions of placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
26
December 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France
 
NCT01268033
I08013
No
University Hospital, Limoges
University Hospital, Limoges
Hoffmann-La Roche
Principal Investigator: Vincent GUIGONIS, MD CHU Limoges
University Hospital, Limoges
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP