NCT05596708

Study of Telitacicept in Patients With Refractory IgA Nephropathy

A Single-arm, Forward-looking, Exploratory Clinical Study of Telitacicept in Patients With Refractory IgA Nephropathy

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to explore the effectiveness and safety of Telitacicept in adults with refractory IgA nephropathy. The main questions it aims to answer are: * To evaluate the clinical efficacy of Telitacicept in patients with refractory IgA nephropathy. * To evaluate the safety and adverse reaction of Telitacicept in patients with refractory IgA nephropathy. Participants will be subcutaneously injected with 240mg of Telitacicept once per week. Study subject: After 6 months of sequential treatment with renin-angiotensin system (RAS) blockers or glucocorticoids, patients with pathological biopsy of 0.7≥5 g/24 hours of proteinuria was confirmed as refractory IgA nephropathy.

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
DRUG	Telitacicept	Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for 104 weeks.

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-06-30
• Completion: 2026-09-30
• First posted: 2022-10-27
• Last updated: 2023-02-24

Locations

1 site across 1 country: China