NCT04494438

Rituximab for Idiopathic Nephrotic Syndrome

Rituximab in Patients With Low Dose Steroid-dependent Idiopathic Nephrotic Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Istituto Giannina Gaslini · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

Summary

Open-label, randomized, controlled trial due to value whether the monoclonal antibody rituximab is non-inferior to steroids in maintaining remission in juvenile forms of SDNS. The investigators will enroll 30 pediatric patients affected by idiopathic nephrotic syndrome, who have been in treatment with steroids for at least one year. The lowest dose of drug required to maintain a stable remission will be between 0.4 and 0.7 mg/ kg/ day. This trial provides an initial run-in phase of one month during wich remission will be achieved by means of a standard oral prednisone course. Once remission has been achieved children will be randomized in a parallel arm open label RCT to continue prednisone alone for one month (control) or to add a single intravenous infusion of rituximab (375 mg/m2 - intervention). Prednisone will be tapered in both arms after one month.

Conditions

• Idiopathic Nephrotic Syndrome

Interventions

Type	Name	Description
DRUG	Rituximab

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2020-07-31
• Last updated: 2023-01-04

Locations

1 site across 1 country: Italy