Efficacy of Rituximab For the Treatment of Calcineurin Inhibitors Dependent Nephrotic Syndrome During Childhood (NEPHRUTIX)
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|ClinicalTrials.gov Identifier: NCT01268033|
Recruitment Status : Completed
First Posted : December 29, 2010
Last Update Posted : March 23, 2015
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.
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
two infusions of Rituximab - at the dose of 375 mg/m²
two infusions - at the dose of 375 mg/m²- will be administered at one week of interval
Placebo Comparator: placebo
two infusions of placebo
two infusions - at the dose of 375 mg/m² - will be administrered at one week of interval
- 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
- - dosing of rituximab for toxicity during and/or after infusion [ Time Frame: 5 months ]- toxicity during and/or after infusion
- - dosing of rituximab for pharmacokinetics [ Time Frame: 5 months ]- dosing of rituximab for pharmacokinetics
- - dosing of lymphocyte [ Time Frame: 5 months ]- lymphocyte phenotyping
- Pediatric Quality of life inventory [ Time Frame: 5 months ]Pediatric Quality of life inventory
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
|Principal Investigator:||Vincent GUIGONIS, MD||CHU Limoges|