Abstract: TH-PO346
Safety and Efficacy of WS016 in Patients with Hyperkalemia in China from a Phase 2 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
- Song, Aiyun, Waterstone Pharmaceutical (Wuhan) Co., LTD, Wuhan, China
- Zuo, Li, Peking University People's Hospital, Beijing, China
- Zhao, Jianrong, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, China
- Ji, Zhen Hua, Central Hospital affiliated to Shenyang Medical College, Shenyang, China
- Peng, Qingfeng, Zhuzhou Central Hospital, Zhuzhou, Huna, China
- Xu, Wen Chuan, Wuhan Fourth Hospital, Wuhan, Hubei, China
- Tian, N a, Affiliated Hospital of Ningxia Medical University, Yinchuan, Ningxia, China
- Zhang, Qinghong, Taihe Hospital of Shiyan City, Shiyan, China
- Xue, Xianjun, Puyang Oilfield General Hospital, Puyang, Henan, China
- Huang, Xinzhong, Affiliated Hospital of Nantong Medical University, Nantong, China
- Sun, Changyou, Tancheng County First People's Hospital, Tancheng, Shandong, China
- Niu, Jianying, Fifth People's Hospital of Shanghai Fudan University, Shanghai, China
- Yan, Fan, Waterstone Pharmaceutical (Wuhan) Co., LTD, Wuhan, China
- Zhang, Faming, Waterstone Pharmaceutical (Wuhan) Co., LTD, Wuhan, China
Group or Team Name
- WS016 Phase 2 China Study Group.
Background
Hyperkalemia is a common electrolyte disorder that is associated with serious cardiac dysrhythmias and increased mortality.WS016 is a highly selective cation exchanger that entraps potassium in the intestinal tract thus could lower serum potassium levels in patients with hyperkalemia.
Methods
140 patients with hyperkalemia were randomly assigned to receive either WS016(dose of 3g, 6g, 12g) or placebo three times daily for 48 hours(acute phase) in this multicenter, two-stage, double-blind, phase 2 trial. Patients with normokalemia at 48 hour in WS016 group were randomly assigned to receive WS016 or placebo once daily from day 3 to day 14(maintenance phase). The primary endpoint was the exponential rate of change of serum potassium at 48 hour.
Results
At 48 hours, there were absolute mean reduction of 0.58 mmol/L,0.51 mmol/L,0.86 mmol/L in the 3g,6g,12g group respectively, and 0.35 mmol/L in placebo group. The reduction at 1 hour after the first 3g dose of WS016 was 0.24mmol/L, while 0.05 mmol/L in the placebo group, respectively. The maxim reduction was 0.98,1.16 mmol/L in 3g and 12g group, 0.50 mmol/L in placebo group at 26 hour. The proportion of patients who reached the normokalemia were 71.4%, 70%,80%,45.7% in 3g,6g,12g, and placebo group.
At the end of 12-day maintenance treatment, the proportion of patients who maintain normokalemia was 63% in treatment group and 40% in placebo group. The mean increase was 0.27 VS.0.44 mmol/L in 6g and its corresponding placebo group, 0.49 VS.0.68 mmol/L in 12g and its corresponding placebo group.
During acute phase adverse events were reported in 26.9% patients in the WS016 group and 20% in the placebo group; and 32.3% patients in the WS016 group and 35.3% in the placebo group during the maintenance phase. Most of AEs were grade 1.There is only 1 SAE found in 12g group, and is not related with WS016. Only 2 patients were reported with hypokalemia graded as 1 in 12g group and recovered without rescue treatment. No patients reported with other abnormal electrolytes and edema.
Conclusion
WS016 can reduce potassium levels during 48 hours rapidly and maintain more patients within the normokalemia duiring 12-day maintenance phase compared with placebo. It was suggested that WS016 is effective and safety for hyperkalemic patients.
Funding
- Commercial Support – Waterstone Pharmaceutical (Wuhan) Co., LTD