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Efficacy of monoclonal anti CD 20 antibodies in steroid and cyclosporin dependent nephrotic syndrome in children - ND

Efficacy of monoclonal anti CD 20 antibodies in steroid and cyclosporin dependent nephrotic syndrome in children - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-004486-26-IT
Enrollment
Unknown
Registered
2009-03-19
Start date
2008-10-07
Completion date
Unknown
Last updated
2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrotic Syndrome MedDRA version: 9.1 Level: LLT Classification code 10029164 Term: Nephrotic syndrome

Interventions

Sponsors

ISTITUTO GIANNINA GASLINI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Positicity of autoantibodies and low levels of C3

Design outcomes

Primary

MeasureTime frame
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

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 27, 2026