The Efficacy and Safety of Treatment with Telitacicept in Antineutrophil Cytoplasmic Antibody-associated Nephritis (AAGN)
- Sponsor
- Renmin Hospital of Wuhan University
- Study ID
- NCT06656962
- Phase
- PHASE1/PHASE2
- Status
- Active Not Recruiting
Conditions
- Antineutrophil Cytoplasmic Antibody (ANCA)-associated Nephritis (AAGN)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Telitacicept 160mg — DRUGTelitacicept for Injection combined with standard therapy (Prednisone and Cyclophosphamide) for the treatment of ANCA-associated nephritis (AAGN).
- Prednisone (and methylprednisolone) — DRUGMethylprednisone shock therapy (500mg, 3 times), followed by Prednisone (1 mg·kg·d and a pre-determined tapering guideline \[PEXIVAS regimen\]).
- Cyclophosphamide — DRUGCyclophosphamide, intravenous injection, once every 2 to 3 weeks, 0.75 g/m² each time, the maximum cumulative dose of 8g
Study Details
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.
Key Dates
- Start date
- Oct 10, 2024
- Status verified
- Oct 2024
- Primary completion
- Dec 30, 2025
- Completion
- Oct 30, 2026
Study Design
- Enrollment
- 15 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: The Telitacicept treatment group
Primary Outcome Measure
The complete remission rate of AAGN [ Time Frame: 24 weeks ]