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NCT04783675: RTXFIRPedINS
Efficacy and Safety of Rituximab in the First Episode of Pediatric Idiopathic Nephrotic Syndrome
Phase 2 trial testing Rituximab in Steroid-Sensitive Nephrotic Syndrome in 44 participants. Completed in 17 January 2023.
17 January 2023
Quick facts
| Lead sponsor | Children's Hospital of Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 13 April 2021 |
| Primary completion | 17 January 2023 |
| Estimated completion | 17 January 2023 |
| Sites | 8 locations across China |
Drugs / interventions tested
- Rituximab — full drug profile →
Conditions studied
- Steroid-Sensitive Nephrotic Syndrome — all drugs for Steroid-Sensitive Nephrotic Syndrome →
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):
-
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 -
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 -
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:
- PubMed search for NCT04783675
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rituximab
Trials testing the same drug.
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Other recruiting trials for Steroid-Sensitive Nephrotic Syndrome
Currently open trials in the same condition.
- NCT05786768 — Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syn · Phase 2, PHASE3 · recruiting
- NCT06065852 — National Registry of Rare Kidney Diseases · recruiting
Other Children's Hospital of Fudan University trials
Trials by the same sponsor.
- NCT04955821 — Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS · not yet recruiting
- NCT05862688 — A Cohort Study on Anti-microbial Stewardship in PICU · not yet recruiting
- NCT05595239 — Blood Purification in Septic Children · NA · not yet recruiting
- NCT07325903 — Research of Integrated Traditional Chinese and Western Medicine on Precocious Puberty · EARLY_PHASE1 · not yet recruiting
- NCT07141615 — Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of P · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04783675 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Fudan University
- Last refreshed: 11 July 2023
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing