Abstract: TH-PO1278
Long-Term Safety of Gosicalcetide in Patients with Secondary Hyperparathyroidism Receiving Hemodialysis
Session Information
- Late-Breaking Research Posters
October 22, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- 502 Bone and Mineral Metabolism: Clinical
Authors
- Zuo, Li, Peking University People's Hospital, Beijing, China
- Gan, Liangying, Peking University People's Hospital, Beijing, China
- Bi, Guangyu, Northern Jiangsu People's Hospital, Yangzhou, China
- Gao, Bi hu, Affiliated Zhongshan Hospital of Dalian University, Dalian, China
- Zeng, Ying, The Second Affiliated Hospital of Soochow University, Suzhou, China
- Ye, Hong, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
- Liu, Aiying, Baotou Central Hospital, Baotou, China
- Li, Xiaowei, Fuyang People's Hospital, Fuyang, China
- Qin, Yuan, Guilin People's Hospital, Guilin, China
- Zhang, Zhijian, Wuxi People's Hospital, Wuxi, Jiangsu, China
- Jin, Yun, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Lianyungang, China
- Yang, Xue, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Lianyungang, China
- Pan, Lili, Shanghai Hansoh BioMedical Co., Ltd., Shanghai, China
Background
Gosicalcetide (HS-10568 or SHR6508) is a novel intravenously administrated calcimimetic for treating secondary hyperparathyroidism (SHPT) in patients (pts) receiving hemodialysis (HD). The long-term safety of gosicalcetide remains unclear.
Methods
This was a multicenter, single-arm, phase 2 trial to assess the long-term safety of gosicalcetide in pts receiving HD with SHPT, intact PTH (iPTH) ≥300 pg/mL (NCT06236295). The estimated total treatment duration was ≥26 weeks. The starting dose was 5 mg with a range of 2.5–20 mg. Dose was adjusted based on iPTH and serum calcium. Primary endpoint was incidence and severity of treatment emergent adverse events (TEAEs).
Results
A total of 303 pts from 47 centers were enrolled. The mean (SD) age was 49.1 (11.4) years, and 65.3% were male. Mean (SD) baseline iPTH was 777.3 (481.8) pg/mL. The median (Q1, Q3) treatment duration was 74.7 weeks (66.7, 76.7). Ninety-nine percent of participants reported at least 1 TEAE, most were mild to moderate in severity. 17 (5.6%) pts reported hypocalcaemia, and most were mild to moderate except 1 severe case which was deemed unlikely related to gosicalcetide by investigator. Common TEAEs (incidence ≥10%) are shown in the Table. Gosicalcetide induced a sustained reduction in iPTH (Figure). At all EAPs, at least 71% of pts achieved an iPTH level of <300 pg/mL.
Conclusion
Gosicalcetide showed favorable long-term safety and sustained PTH-lowering efficacy in patients receiving HD with SHPT.
Acknowledgment
This study was funded and sponsored by Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Table. Safety summary
Figure. Percentage change from baseline in iPTH
Funding
- Commercial Support – Jiangsu Hengrui Pharmaceuticals Co., Ltd.