Kidney Week

Abstract: TH-PO350

Effectiveness, Safety, and Treatment Patterns of Sodium Zirconium Cyclosilicate (SZC) for Hyperkalemia (HK) in China: Final Results of the Actualize Study

Session Information

• Sodium, Potassium, and Volume Disorders: Clinical
  October 24, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Fluid, Electrolytes, and Acid-Base Disorders

• 1102 Fluid, Electrolyte, and Acid-Base Disorders: Clinical

Authors

• Lin, Hong Li, First Affiliated Hospital of Dalian Medical University, Dalian, Dalian, China

Hong Li Lin, MD

• Shen, Nan, First Affiliated Hospital of Dalian Medical University, Dalian, Dalian, China

Nan Shen, MD

• Zhang, Lihong, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

Lihong Zhang, MD

• Yang, Jing, Hefei First People's Hospital, Hefei, Anhui, China

Jing Yang, MD

• Lin, Yongqiang, Wenzhou Integrated Chinese and Western Medicine Hospital, Wenzhou, Zhejiang, China

Yongqiang Lin, MD

• Liu, Xinyu, Nanyang Central Hospital, Nanyang, Henan, China

Xinyu Liu

• Cai, Xudong, Ningbo Traditional Chinese Medicine Hospital, Ningbo, Zhejiang, China

Xudong Cai, MD

• Cao, Juan, Taixing People's Hospital, Taixing, Jiangsu, China

Juan Cao, MD

• Zhu, Qiang, Xinghua People's Hospital, Taizhou, Jiangsu, China

Qiang Zhu, MD

• Luo, Xun, Hunan Provincial People's Hospital, Changsha, Hunan, China

Xun Luo, MD

• Wan, Xin, Nanjing First Hospital, Nanjing, Jiangsu, China

Xin Wan, MD

• Wu, Henglan, The First Hospital of Jiaxing, Jiaxing, Zhejiang, China

Henglan Wu, MD

• Ye, Jianming, Kunshan First People's Hospital, Kunshan, Jiangsu, China

Jianming Ye, PhD

• Shan, Chunyan, Chu Hsien-I Memorial Hospital of Tianjin Medical University, Tianjin, Tianjin, China

Chunyan Shan, MD

• Xie, Hua, Dalian Ruikaer Renal Disease Hospital, Dalian, Liaoning, China

Hua Xie

• Wu, Yifan, Guangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Guangzhou, Guangdong, China

Yifan Wu, MD, PhD

• Cao, Yanping, Handan First Hospital, Handan, Hebei, China

Yanping Cao, MD

• Yang, Lin, Linfen Central Hospital, Linfen, Shanxi, China

Lin Yang, MD

• Yu, Xiaoyong, Shaanxi Provincial Hospital of Traditional Chinese Medicine, Xi'an, Shaanxi, China

Xiaoyong Yu, MD

• Min, Wang Hui, Liaoning Health Industry Group Bensteel General Hospital, Benxi, Liaoning, China

Wang Hui Min, MD

• He, Jingdong, Nuclear Industry 416 Hospital, Chengdu, Sichuan, China

Jingdong He

• Tian, Shaojiang, Shiyan People's Hospital, Shiyan, Hubei, China

Shaojiang Tian, MD

• Wu, Fenglei, Nantong University Affiliated Qidong Hospital, Qidong, Jiangsu, China

Fenglei Wu, MD

• Shi, Yifan, AstraZeneca Investment China Co Ltd, Shanghai, Shanghai, China

Yifan Shi

Background

SZC is a non-absorbed cation exchanger approved in China for treating HK (serum potassium level [sK⁺] >5.0 mmol/L). Actualize is the first real-world study to assess the effectiveness, safety, and treatment patterns of SZC in Chinese patients (pts) with HK.

Methods

This study included adult HK pts taking/willing to take SZC from 40 sites in China. All pts completed 6- month follow-up. As per Chinese label, treatment was categorized as correction (FAS-P1) and maintenance phase (FAS-P2); treatment was discontinued as per the HK threshold at each site (mostly 5.3 or 5.5 mmol/L). The study evaluated changes in sK⁺ and the incidence of adverse events (AEs).

Results

442 and 878 pts were included in FAS-P1 and FAS-P2, respectively. In FAS-P1, with a mean daily SZC dose of 9.5g, mean sK⁺ reduced significantly from 5.8 mmol/L at baseline to 5.0 mmol/L. After correction phase, 51% and 80% of pts had sK⁺ between 3.5-5.0 and 3.5-5.5 mmol/L, respectively. In FAS-P2, with a mean daily SZC dose of 4.2 g, the mean sK⁺ over 6 months was 5.1 mmol/L. The proportions of normokalaemic pts at 6 months by chronic kidney disease (CKD) stage at enrollment are shown in Table 1; in pts with stage 3–4, stage 5/non-hemodialytic and hemodialytic CKD, 59.0%, 63.2% and 51.5%, respectively, had sK⁺ between 3.5-5.0 mmol/L. Incidence rate (per 100 person-days) of AEs was 2.9% and 0.5% in FAS-P1 and FAS-P2, respectively, and that of severe AEs was 0.2% in both. There was no AE leading to treatment discontinuation in FAS-P2 and 0.1% in FAS-P1. Overall, 3.8% and 6.5% of pts experienced oedema and hypokalemia, respectively.

Conclusion

SZC was effective and safe in treating HK in CKD pts, and can be considered as standard treatment for acute and chronic HK in China.

Funding

• Commercial Support – AstraZeneca China