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Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial — STORM  

Nephrotic Syndrome in Children Clinical Trial

Official title:
Study of Rituximab Monotherapy VS Steroid Therapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial

Clinical Trial Summary

The main objective is to evaluate the effectiveness of Rituximab monotherapy versus steroid therapy on children with new-onset nephrotic syndrome within the 52-week follow-up.

Clinical Trial Description

Nephrotic syndrome(NS) -------the most common glomerular disease in children. Steroid, as the mainstream therapy for decades, many patients suffer from adverse effects of it, such as growth impacted, fat, and glaucoma.There is a urgent need for Steroid-sparing therapy. Rituximab, as a chemical monoclonal antibody against the cluster of differentiation antigen 20(CD20), has proved to be effective in patients with frequent-relapse/steroid-dependent NS. It has also been reported to be effective in six adult patients with new-onset NS. Rituximab mono-therapy in new-onset pediatric NS patients is still unclear. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05734794
Study type Interventional
Source The Children's Hospital of Zhejiang University School of Medicine
Contact Jianhua Mao, PHD.MD
Phone 86057186670015
Email maojh88@zju.edu.cn
Status Recruiting
Phase Phase 3
Start date February 9, 2023
Completion date July 30, 2026
View Details
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