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Telitacicept in Pediatric Nephrotic Syndrome
NCT06125405Phase 3
Key facts
- Status
- Recruiting
- Start
- Nov 2023
- Primary completion
- Oct 2026
- Countries
- 1
- Sponsor
- Children's Hospital, Zhejiang University School of Medicine
- Modality
- Fc-Fusion Proteins
- Drugs
- telitacicept
- Conditions
- nephrotic syndrome
01
Overview
Phase 3, open-label, single-arm trial of telitacicept in nephrotic syndrome, sponsored by Children's Hospital, Zhejiang University School of Medicine. Primary endpoint: 1-year relapse-free survival rate. Started Nov 2023; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Telitacicept Group
Telitacicept SC weekly + Standard of Care (Prednisone)
03
Who it enrols
Pediatric patients (2-18 years) with sensitive but frequently relapsing or steroid-dependent nephrotic syndrome, normal renal function, and in remission at enrollment (low proteinuria). Excludes patients with recent use of rituximab (6 months) or other immunosuppressants (3 months), active infections, or secondary nephrotic syndrome.
04
Endpoints
Primary
1-year relapse-free survival rate
Secondary
Relapse of nephrotic syndrome during 12 months after enrollment
Number of relapses during 12 months follow up
The first time to relapse
Cumulative prednisone dosage
Change in hemoglobin of the patients
Change in blood albumin of the patients
Change in renal function of the patients
Change in mass index (BMI) during 12-month period after enrollment
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