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NCT04783675: RTXFIRPedINS

Efficacy and Safety of Rituximab in the First Episode of Pediatric Idiopathic Nephrotic Syndrome

Completed Phase 2 Last updated 11 July 2023
What this trial tests

Phase 2 trial testing Rituximab in Steroid-Sensitive Nephrotic Syndrome in 44 participants. Completed in 17 January 2023.

Timeline
13 April 2021
Primary endpoint
17 January 2023
17 January 2023

Quick facts

Lead sponsorChildren's Hospital of Fudan University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment44
Start date13 April 2021
Primary completion17 January 2023
Estimated completion17 January 2023
Sites8 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital of Fudan University

Who can join

Adults 1 to 18, any sex, with Steroid-Sensitive Nephrotic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main objective is to demonstrate, from the initial episode of nephrotic syndrome (NS) in children with standard prednisolone treatment, once complete remission has occurred, that the use of Rituximab (a single intravenous infusion of 375 mg/m2) may reduce the risk of subsequent relapse during 12-month of follow-up.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Early Rituximab as an Add-On Therapy in Children With the Initial Episode of Nephrotic Syndrome.
    Liu J, Deng F, Wang X, Liu C, et al · · 2024 · cited 9× · PMID 38707815 · DOI 10.1016/j.ekir.2024.02.1395
  2. Protocol for an open-label, single-arm, multicentre clinical study to evaluate the efficacy and safety of rituximab in the first episode of paediatric idiopathic nephrotic syndrome.
    Liu J, Shen Q, Xie L, Wang J, et al · · 2022 · cited 4× · PMID 36223961 · DOI 10.1136/bmjopen-2022-064216
  3. Anti-B Cell Strategy in Nephrotic Syndrome: Beyond Rituximab.
    Jin Y, Xie Y, Fu H, Liu F, et al · · 2025 · cited 2× · PMID 41007627 · DOI 10.3390/biomedicines13092063

Verify or expand the search:

Other trials of Rituximab

Trials testing the same drug.

Other recruiting trials for Steroid-Sensitive Nephrotic Syndrome

Currently open trials in the same condition.

Other Children's Hospital of Fudan University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04783675.

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