Abstract: PO2540
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of Telitacicept in Patients with IgA Nephropathy and Persistent Proteinuria
Session Information
- Late-Breaking Clinical Trials Posters
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1203 Glomerular Diseases: Clinical, Outcomes, and Trials
Authors
- Lv, Jicheng, Peking University First Hospital, Beijing, China
- Liu, Lijun, Peking University First Hospital, Beijing, China
- Hao, Chuan-Ming, Huashan Hospital, Fudan University, Shanghai, China
- Li, Guisen, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
- Fu, Ping, West China Hospital of Sichuan University, Chengdu, China
- Xing, Guangqun, Affiliated Hospital of Qingdao University, Qingdao, China
- Zheng, Hongguang, Affiliated Hospital of Qingdao University, Shenyang, China
- Chen, Nan, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Caili, Wang, The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou, China
- Luo, Ping, The Second Hospital of Jilin University, Changchun, China
- Qiong, Xie De, The Second People's Hospital of Yibin, Yibin, China
- Zuo, Li, Peking University People's Hospital, Beijing, China
- Wang, Yue, Peking University Third Hospital, Beijing, China
- Li, Rongshan, The Affiliated People's Hospital of Shanxi Medical University, Taiyuan, China
- Mao, Yonghui, Beijing Hospital, Beijing, China
- Shaoshao, Dong, The People's Hospital of Wenzhou, Wenzhou, China
- Zhang, Pengfei, Heping hospital affiliated to Changzhi Medical College, Changzhi, China
- Zheng, Hui Xiao, The Second Affiliated Hospital of Xingtai Medical College, Xingtai, China
- Wang, Wenxiang, RemeGen Co., Ltd, Yantai, China
- Li, Lin, RemeGen Co., Ltd, Yantai, China
- Jiao, Wenjuan, RemeGen Co., Ltd, Yantai, China
- Fang, Jianmin, Shanghai Tongji Hospital, Shanghai, China
- Zhang, Hong, Peking University First Hospital, Beijing, China
Background
Until now there are no approved specific therapy for IgA nephropathy. Telitacicept is a novel fusion protein composed of transmembrane activator and CAML interactor (TACI) and the Fc portion of IgG, which targets and neutralizes B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). This phase II study evaluated the efficacy and safety of telitacicept compared with placebo, when added to standard therapy in patients with IgAN with high risk for progression
Methods
In this randomized, double-blind, placebo-controlled trial, we enrolled patients with proteinuria ≧ 0.75g/day despite optimal supportive care, who were randomized 1:1:1 to receive subcutaneous telitacicept at 160 mg, 240 mg or placebo weekly for 24 weeks. The primary endpoint was a change in 24-hour proteinuria at week 24; key secondary endpoints included change in eGFR.
Results
Overall 44 participants were randomized in this study: placebo (14) and telitacicept 160mg (16) and 240mg (14). A consistent, dose-dependent reduction in serum IgA(Figure 1A), IgG and IgM were observed through Week 24 . Telitacicept therapy was associated with a 49% decrease from baseline in mean proteinuria (change in proteinuria vs placebo -0.88; 95% CI-1.57~-0.20; p=0.013) received 240mg, and 25% reduction but non-significantly in 160mg arm (-0.29; -0.95~0.37; p=0.389) (Figure 1B). Estimated GFR remained stable over time (Figure 1C). TEAEs were reported similar in all groups. TEAEs were mild or moderate in severity, with no severe TEAEs reported.
Conclusion
Telitacicept reduced proteinuria in patients with IgA nephropathy with high risk. This effect is indicative of a reduced risk of future kidney progression.
Figure 1. Mean change in IgA, proteinuria and eGFR from baseline
Funding
- Commercial Support –