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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01268033
Recruitment Status : Completed
First Posted : December 29, 2010
Last Update Posted : March 23, 2015
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Childhood Idiopathic Nephrotic Syndrome Drug: Rituximab Drug: Placebo Phase 2 Phase 3

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014


Arm Intervention/treatment
Experimental: Rituximab
two infusions of Rituximab - at the dose of 375 mg/m²
Drug: Rituximab
two infusions - at the dose of 375 mg/m²- will be administered at one week of interval

Placebo Comparator: placebo
two infusions of placebo
Drug: Placebo
two infusions - at the dose of 375 mg/m² - will be administrered at one week of interval




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268033


Locations
Show Show 24 study locations
Sponsors and Collaborators
University Hospital, Limoges
Hoffmann-La Roche
Investigators
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Principal Investigator: Vincent GUIGONIS, MD CHU Limoges

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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01268033    
Other Study ID Numbers: I08013
First Posted: December 29, 2010    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: March 2015
Keywords provided by University Hospital, Limoges:
rituximab
idiopathic nephrotic syndrome
minimal change disease
focal and segmental glomerulosclerosis
Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Nephrosis, Lipoid
Syndrome
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Rituximab
Calcineurin Inhibitors
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action