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NCT05850546
Rituximab in the First Episode of Paediatric Nephrotic Syndrome
Phase 3 trial testing Rituximab in Steroid-Sensitive Nephrotic Syndrome in 138 participants. Not yet recruiting.
30 July 2026
Quick facts
| Lead sponsor | Children's Hospital of Fudan University |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 138 |
| Start date | 1 March 2025 |
| Primary completion | 30 July 2026 |
| Estimated completion | 28 December 2026 |
| Sites | 3 locations across China |
Drugs / interventions tested
- Rituximab — full drug profile →
- Corticosteroid — 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 study will be a randomized, open-label trial in children with the initial episode of SSNS and whose state of complete remission after received standard prednisolone, to determine whether rituximab (a single intravenous infusion of 375 mg/m2) would be noninferior to corticosteroid alone in maintaining complete disease remission during 12-month of follow-up.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05850546
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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
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- 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 NCT05850546 (US National Library of Medicine, public domain)
- 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: 22 January 2025
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/NCT05850546.
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