Efficacy of monoclonal anti CD 20 antibodies in steroid and cyclosporin dependent nephrotic syndrome in children - ND
- Conditions
- ephrotic SyndromeMedDRA version: 9.1Level: LLTClassification code 10029164Term: Nephrotic syndrome
- Registration Number
- EUCTR2008-004486-26-IT
- Lead Sponsor
- ISTITUTO GIANNINA GASLINI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Age between 1-16 years 2-clinical picture of idiopathic nephrotic syndrome
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Positicity of autoantibodies and low levels of C3
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To define efficacy of antiCD20 antibodies to mantain remission in patients with nephrotic syndrome dependent to conventional drugs;Secondary Objective: To induce and mantain remission of proteinuria in children with nephrotic syndrome dependent to steroids and cyclosporin;Primary end point(s): To define efficacy of antiCD20 antibodies to mantain remission in patients with nephrotic syndrome dependent to conventional drugs
- Secondary Outcome Measures
Name Time Method