Abstract: TH-PO1189
Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Evaluating the Efficacy and Safety of HRS-1780 Tablets in Patients with CKD
Session Information
- Late-Breaking Research Posters
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Liu, Zhihong, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China
- Zhang, Haitao, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China
- Li, Xiaowei, Fuyang People’s Hospital of Anhui Medical University, Fuyang, China
- Zheng, Dongwen, The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital), Dongguan, China
- Bi, Guangyu, Northern Jiangsu People's Hospital, Yangzhou, China
- Ye, Zi, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
- Dong, Xue, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
- Wei, Yuehan, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
- Bao, Manchen, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
- Cheng, Gang, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
- Huang, Rong, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
- Dong, Qiuli, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
- Liu, Shuai, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
Background
HRS-1780 is a selective non-steroidal MRA in development. This study aimed to evaluate the efficacy and safety of HRS-1780 tablets in CKD patients.
Methods
In this study, patients with eGFR from 30 to 90 mL/min/1.73 m2, UACR from 300 to 3000 mg/g, HbA1c < 9.0%, blood potassium ≤ 4.8 mmol/L and maintaining treatment with the maximum tolerated dose of ACEi/ARB for at least 4 weeks, were randomized 1:1:1 to the HRS-1780 10 mg, 20 mg and placebo groups. The primary endpoint was the percentage change from baseline to Week 13 in UACR.
Results
In total, 134 CKD patients, 34.3% of which combined with T2DM, were randomized and received at least one dose of study drug. The baseline demographics and clinical characteristics were balanced across all the treatment groups. At Week 13, the placebo-corrected percentage change from baseline in UACR was -29.9% (P=0.0112) and -53.5% (P<0.0001) with HRS-1780 10 and 20 mg groups, respectively. The placebo-corrected percentage change from baseline in 24-hour urine protein quantification were -29.4% (P=0.0068) and -47.3% (P<0.0001) with HRS-1780 10 mg and 20 mg groups, respectively. In safety, the incidence of TEAE was 65.9%, 64.4% and 55.6% with HRS-1780 10 mg, 20 mg and placebo groups, respectively. The incidence of hyperkalaemia (defined by serum K+ > 5.5 mmol/L) was 4.5% and 15.6% with HRS-1780 10 mg and 20 mg groups, respectively.
Conclusion
Treatment of HRS-1780 showed good efficacy and safety profile in CKD patients.
Funding
- Commercial Support – Jiangsu Hengrui Pharmaceuticals Co., Ltd.