Abstract: TH-PO130
Paricalcitol Capsule (HR081702) for Secondary Hyperparathyroidism (SHPT) in Stages 3 and 4 CKD: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study
Session Information
- CKD-MBD: Clinical
October 24, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- 502 Bone and Mineral Metabolism: Clinical
Authors
- Chen, Jianghua, Kidney Disease Center, the First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
- Cheng, Jun, Kidney Disease Center, the First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
- Du, Xiaoying, Kidney Disease Center, the First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
- Liu, Changhua, Northern Jiangsu People's Hospital, Yangzhou, China
- Luo, Ping, The Second Hospital of Jilin University, Changchun, China
- Chang, Wenxiu, Tianjin First Central Hospital, Tianjin, China
- Zhang, Yanning, General Hospital of the Northern Theatre, Shenyang, China
- Lin, Hong Li, First Affiliated Hospital of Dalian Medical University, Dalian, China
- Wang, Lihua, Second Hospital of Shanxi Medical University, Taiyuan, China
- Zhou, Hua, Shengjing Hospital of China Medical University, Shenyang, China
- Li, Wenbin, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan, China
- Yu, Xiaoyong, Shaanxi Traditional Chinese Medicine Hospital, Xi'an, China
- Lu, Wanhong, the First Affiliated Hospital, School of Medicine, Xi'an Jiaotong University, Xi'an, China
- Chen, Chaosheng, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
- Zhou, Linghui, The First Affiliated Hospital of Xiamen University, Xiamen, China
- Sun, Xiaoyi, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China
- Xu, Lingling, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China
Background
Paricalcitol capsule is a good choice to treat SHPT as a vitamin D analogue with a convenient dosage form for patients. This study aimed to investigate the efficacy and safety of paricalcitol capsule (HR081702) in stages 3/4 CKD patients with SHPT.
Methods
This was a multicenter, randomized, double-blind, placebo-controlled, phase 3 study in Chinese adult patients in stages 3/4 CKD with SHPT (ClinicalTrials.gov, NCT04994080). Patients were enrolled if, in the screening period and run-in period, the mean serum intact parathyroid hormone (iPTH) was ≥150 pg/mL (≥120 pg/mL in both periods), serum calcium level was between 8.0 and 10.0 mg/dL (1.99 and 2.50 mmol/L), and serum phosphorus level was ≤5.2 mg/dL (1.68 mmol/L). Eligible patients were randomized (2:1) to receive HR081702 or placebo orally once a day for 24 weeks, with the initial dose determined by iPTH level and adjusted depending on subsequent serum iPTH, calcium, and phosphorus levels. The primary endpoint was the proportion of patients with at least two consecutive iPTH reductions of ≥30% from baseline within 24 weeks of treatment.
Results
A total of 90 patients were randomized (60 in HR081702 group and 30 in placebo group) with similar baseline characteristics between the two groups. During the 24 weeks treatment period, 91.7% of patients in the HR081702 group achieved two consecutive reductions of ≥30% from baseline in iPTH levels, compared with 16.7% of patients in the placebo group (difference, 75.0% [95% CI 59.9-90.1]; P<0.0001). Furthermore, 68.3% of HR081702-treated patients achieved four consecutive decreases of ≥30% in iPTH levels from baseline, compared with 6.7% of placebo-treated patients. There were no obvious differences in the excretion of calcium and phosphorus or in the decline of kidney function between the two groups. Treatment-related adverse events were reported by 50% in HR081702 group and 26.7% in placebo group (all were mild or moderate). The most common ones were hyperphosphatemia and urinary tract infection.
Conclusion
Paricalcitol capsule (HR081702) was an effective and safe treatment for stages 3/4 CKD patients with SHPT.
Funding
- Commercial Support – Jiangsu Hengrui Pharmaceuticals Co., Ltd