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.
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