Efficacy of Rituximab For the Treatment of Calcineurin Inhibitors Dependent Nephrotic Syndrome During Childhood (NEPHRUTIX)
This study is currently recruiting participants.
Verified October 2012 by University Hospital, Limoges
Sponsor:
University Hospital, Limoges
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01268033
First received: December 15, 2010
Last updated: October 22, 2012
Last verified: October 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Childhood Idiopathic Nephrotic Syndrome |
Drug: Rituximab Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by University Hospital, Limoges:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- - 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
| Estimated Enrollment: | 26 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268033
Contacts
| Contact: Vincent GUIGONIS, MD | 05 55 05 63 58 | vincent.guigonis@chu-limoges.fr |
| Contact: Nicolas RODIER, Nurse | 05 55 05 86 06 | nicolas.rodier@chu-limoges.fr |
Locations
| Belgium | |
| Queen Fabiola Universitary Children's Hospital | Not yet recruiting |
| Brussels, Belgium, 1020 | |
| Contact: Thierry SCHURMANS, MD thierry.schurmans@huderf.be | |
| Principal Investigator: Thierry SCHURMANS, MD | |
| France | |
| Chu Amiens | Recruiting |
| Amiens, France, 80054 | |
| Contact: Bernard BOUDAILLIEZ, MD 03 22 66 82 66 boudailliez.bernard@chu-amiens.fr | |
| Principal Investigator: Bernard BOUDAILLIEZ, MD | |
| Chu Besancon | Recruiting |
| Besancon, France, 25030 | |
| Contact: François NOBILI, MD 03 81 21 88 15 fnobili@chu-besancon.fr | |
| Principal Investigator: François NOBILI, MD | |
| Chu Bordeaux | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Brigitte LLANAS, MD 05 56 79 87 25 brigitte.llanas@chu-bordeaux.fr | |
| Principal Investigator: Brigitte LLANAS, MD | |
| Chu Brest | Recruiting |
| Brest, France, 29609 | |
| Contact: Loïc De PARSCAU, MD 02 98 22 36 66 loic.deparscau@chu-brest.fr | |
| Principal Investigator: Loïc De PARSCAU, MD | |
| CHU CAEN | Recruiting |
| Caen, France, 14033 | |
| Contact: Philippe ECKART, MD 02 31 27 24 43 eckart-p@chu-caen.fr | |
| Principal Investigator: Philippe ECKART, MD | |
| Chu Clermont Ferrand | Recruiting |
| Clermont Ferrand, France, 63058 | |
| Contact: Jean-Bernard PALCOUX, MD 04 73 75 00 58 jbpalcoux@chu-clermontferrand.fr | |
| Principal Investigator: Jean-Bernard PALCOUX, MD | |
| Chu Grenoble | Recruiting |
| Grenoble, France, 38043 | |
| Contact: Guylhène BOURDAT-MICHEL, MD 04 76 76 58 94 gbourdat@chu-grenoble.fr | |
| Principal Investigator: Guylhène BOURDAT-MICHEL, MD | |
| Chu Lille | Recruiting |
| Lille, France, 59800 | |
| Contact: Maud DEHENNAULT, MD 03 20 44 46 95 mdehennault@chru-lille.fr | |
| Principal Investigator: Maud DEHENNAULT, MD | |
| Chu Limoges | Recruiting |
| Limoges, France, 87042 | |
| Contact: Vincent GUIGONIS, MD 05 55 05 63 58 vincent.guigonis@chu-limoges.fr | |
| Principal Investigator: Vincent GUIGONIS, MD | |
| AP-HM - Hôpital La Timone | Recruiting |
| Marseille, France, 13385 | |
| Contact: Michel TSIMARATOS, MD 04 91 38 67 42 michel.tsimaratos@mail.ap-hm.fr | |
| Principal Investigator: Michel TSIMARATOS, MD | |
| Chu Montpellier | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Denis MORIN, MD 04 67 33 66 02 d-morin@chu-montpellier.fr | |
| Principal Investigator: Denis MORIN, MD | |
| Chu Nantes | Recruiting |
| Nantes, France, 44033 | |
| Contact: Gwenaelle ROUSSEY, MD 02 40 08 35 80 gwenaelle.roussey@chu-nantes.fr | |
| Principal Investigator: Gwenaelle ROUSSEY, MD | |
| CHU NICE | Recruiting |
| Nice, France, 06202 | |
| Contact: Etienne BERARD, MD 04 92 03 64 41 berard.e@chu-nice.fr | |
| Principal Investigator: Etienne BERARD, MD | |
| AP-HP - Hôpital Necker | Recruiting |
| Paris, France, 75015 | |
| Contact: Patrick NIAUDET, MD 01 44 49 44 63 niaudet@necker.fr | |
| Principal Investigator: Patrick NIAUDET, MD | |
| AP-HP - Hôpital Trousseau | Recruiting |
| Paris, France, 75571 | |
| Contact: Tim ULINSKI, MD 01 44 73 60 32 tim.ulinski@trs.aphp.fr | |
| Principal Investigator: Tim ULINSKI, MD | |
| CHU REIMS - American Memorial Hospital | Recruiting |
| Reims, France, 51092 | |
| Contact: Christine PIETREMENT, MD 03 26 78 72 45 christinepietrement@yahoo.fr | |
| Principal Investigator: Christine PIETREMENT, MD | |
| Chu Rennes | Recruiting |
| Rennes, France, 35000 | |
| Contact: Sophie TAQUE, MD 02 99 26 71 62 sophie.taque@chu-rennes.fr | |
| Principal Investigator: Sophie TAQUE, MD | |
| Chu Rouen | Recruiting |
| Rouen, France, 76031 | |
| Contact: Gilbert LANDTHALER, MD 02 32 88 82 16 gilbert.landthaler@chu-rouen.fr | |
| Principal Investigator: Gilbert LANDTHALER, MD | |
| Chu Saint Etienne | Recruiting |
| Saint Etienne, France, 42055 | |
| Contact: Marie-Pierre LAVOCAT, MD 04 77 82 80 29 m.pierre.lavocat@chu-st-etienne.fr | |
| Principal Investigator: Marie-Pierre LAVOCAT, MD | |
| Chu Strasbourg | Recruiting |
| Strasbourg, France, 67098 | |
| Contact: Michel FISCHBACH, MD 03 88 12 80 00 michel.fischbach@chru-strasbourg.fr | |
| Principal Investigator: Michel FISCHBACH, MD | |
| Chu Toulouse | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Stéphane De CRAMER, MD 05 34 55 87 16 decramer@chu-toulouse.fr | |
| Principal Investigator: Stéphane DE CRAMER, MD | |
| Chu Tours | Recruiting |
| Tours, France, 37044 | |
| Contact: Hubert NIVET, MD 02 47 47 37 46 nivet@med.univ-tours.fr | |
| Principal Investigator: Hubert NIVET, MD | |
| Chu Nancy | Recruiting |
| Vandoeuvre les Nancy, France, 54511 | |
| Contact: Jean-Luc ANDRE, MD 03 83 15 47 41 jl.andre@chu-nancy.fr | |
| Principal Investigator: Jean-Luc ANDRE, MD | |
Sponsors and Collaborators
University Hospital, Limoges
Hoffmann-La Roche
Investigators
| Principal Investigator: | Vincent GUIGONIS, MD | CHU Limoges |
More Information
No publications provided
| Responsible Party: | University Hospital, Limoges |
| ClinicalTrials.gov Identifier: | NCT01268033 History of Changes |
| Other Study ID Numbers: | I08013 |
| Study First Received: | December 15, 2010 |
| Last Updated: | October 22, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Limoges:
|
rituximab idiopathic nephrotic syndrome minimal change disease focal and segmental glomerulosclerosis |
Additional relevant MeSH terms:
|
Nephrosis, Lipoid Nephrotic Syndrome Nephrosis Kidney Diseases Urologic Diseases Rituximab |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013