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

Recruiting Phase 3 Interventional Study
Nephrotic Syndrome in Children Rituximab
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
The Children's Hospital of Zhejiang University School of Medicine · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. New-onset idiopathic nephrotic syndrome 2. Glomerular filtration rate (eGFR) ≥90 ml/min per 1.73 m2 at study entry. Exclusion Criteria: 1. Glomerular hematuria: Urine red blood cell counts≥ 10/high power field(HP), ≥ 3 times within 2 weeks; 2. Continuous hypocomplementaemia…
Contacts

Jianhua Mao, PHD.MD

86057186670015

maojh88@zju.edu.cn

CONTACT

Fei Liu

alexdevin@163.com

CONTACT