Abstract: FR-PO0821
Single-Arm, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy of Low-Dosage Administration of Telitacicept in IgAN
Session Information
- Glomerular Clinical Trials: From Data to Impact
November 07, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Wei, Xin, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
- Zeng, Honghui, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
- Li, Siyu, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
- Wang, Ying, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
- Xiao, Jun, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
- Jiang, Lei, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
- Yan, Yan, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Background
Telitacicept is a fusion protein that neutralizes IgAN validated targets: BAFF and APRIL .This study is aim to evaluate the efficacy of Telitacicept with a low-dose administration in IgAN .
Methods
Eligible participants had an eGFR ≥30 ml/min per 1.73 m2 , proteinuria ≥0.75 g/d or UPCR≥0.5 despite optimal supportive therapy.All participants received a low-dose administration: 1) Stage 1: 160 mg /week for weeks 1 to 12, 2) Stage 2: 160 mg / 2 weeks for weeks 13 to 24, and 3) Stage 3: 160 mg/4 weeks for weeks 25 to 48.
Results
30 participants have enrolled and 9 participants have completed Stage 2. Low-dose administration of Telitacicept reduced proteinuria by 56.8% at week 24 from baseline (1.25±0.32 vs 0.54±0.38，P =0.01) and proteinuria did not increase after taper. The eGFR remained stable over time. No significant change in Immunoglobulin A, G and M.
Conclusion
The low-dose administration of Telitacicept effectively reduced the proteinuria and could be a cost-effective treatment for IgAN.
Table 1． Baseline characteristics of participants
| Characteristics | All (n = 30) |
| Age, mean (SD), yr | 41.43（12.59） |
| Female sex, n (%) | 21（65.60%） |
| Time from diagnosis to start of treatment, median (IQR), days | 291.5（1405.0） |
| UPCR, median (IQR) | 1.14（0.85) |
| eGFR, median (IQR), ml/min /1.73 m2 | 70.30（47.00） |
| *Oxford classification，n(%) | |
| M1 | 21(87.5%) |
| E1 | 4(16.7%) |
| S1 | 15(63.5%) |
| T1 | 9(37.5%) |
| C1 | 10(41.7%) |
*6 patients showed insufficient glomeruli for Oxford classification, T2 and C2 would be excluded.
Figure 1. The change of UPCR(A) and eGFR(B) from baseline.*: P<0.05, ns: no significance.
Figure 2. The change of immunoglobin A(A), G(B) and M(C) through time.