NCT06656962

The Efficacy and Safety of Treatment with Telitacicept in Antineutrophil Cytoplasmic Antibody-associated Nephritis (AAGN)

Renmin Hospital of Wuhan University

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Renmin Hospital of Wuhan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm, open-label exploratory clinical study conducted in subjects with ANCA-associated nephritis (AAGN), aiming to evaluate the efficacy and safety of Telitacicept in the treatment of AAGN.

Conditions

• Antineutrophil Cytoplasmic Antibody (ANCA)-associated Nephritis (AAGN)

Interventions

Type	Name	Description
DRUG	Telitacicept 160mg	Telitacicept for Injection combined with standard therapy (Prednisone and Cyclophosphamide) for the treatment of ANCA-associated nephritis (AAGN).
DRUG	Prednisone (and methylprednisolone)	Methylprednisone shock therapy (500mg, 3 times), followed by Prednisone (1 mg·kg·d and a pre-determined tapering guideline \[PEXIVAS regimen\]).
DRUG	Cyclophosphamide	Cyclophosphamide, intravenous injection, once every 2 to 3 weeks, 0.75 g/m² each time, the maximum cumulative dose of 8g

Timeline

• Start date: 2024-10-10
• Primary completion: 2025-12-30
• Completion: 2026-10-30
• First posted: 2024-10-24
• Last updated: 2024-10-24

Locations

1 site across 1 country: China