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This clinical trial consists of 2 parts, Part A and Part B. Part A consists of a 2-day randomized, double-blind, placebo-controlled corrective phase (CP) and a 28-day randomized, double-blind, placebo-controlled maintenance phase (MP). Part B (open-label extension, OLE) is an open-label, 11-month extension study carried out in participants who come from Part A and meet certain inclusion criteria.
Eligible participants with hyperkalemia will first be randomized in a 5:1 ratio to receive oral WS016 (12g) or placebo three times daily, for a total of six doses over 48 hours.
After the 48-hour corrective treatment, participants whose serum potassium is within the normal range will be re-randomized in a 1:1:1:1 ratio to receive oral WS016 (6g, 12g, or 18g) or placebo once daily for 28 consecutive days.
Participants who complete the 28-day maintenance phase or prematurely discontinue from it due to hyperkalemia or hypokalemia, and who meet the eligibility criteria, will be eligible to enter Part B. In Part B, participants will receive WS016 for 11 months, starting at 12g once daily, with subsequent dose adjustments based on serum potassium levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WS016 (corrective phase) | Experimental |
| |
| Placebo (corrective phase) | Placebo Comparator |
| |
| WS016 (maintenance phase) | Experimental |
| |
| Placebo (maintenance phase) | Placebo Comparator |
| |
| WS016 (open-label extension phase) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WS016 | Drug | WS016 (12g), oral, three times daily for 48 hours, for a total of six doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean serum potassium level during maintenance phase Days 8-29 | Maintenance phase Days 8-29 |
| Measure | Description | Time Frame |
|---|---|---|
| Exponential rate of change in serum potassium during the corrective phase | Through 48 hours corrective phase | |
| Mean change from baseline in serum potassium at all time points of corrective phase | Through 48 hours corrective phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Waterstone Medical Center | Contact | +86 27 87531661 | mpr2024_waterstone@waterstonepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 02 | Recruiting | Bengbu | Anhui | 233000 | China | |
| Investigator Site 03 |
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| Placebo | Drug | Placebo, oral, three times daily for 48 hours, for a total of six doses. |
|
| WS016 | Drug | WS016 (6g, 12g or 18g), oral, once daily for 28 consecutive days. |
|
| Placebo | Drug | Placebo, oral, once daily for 28 consecutive days. |
|
| WS016 | Drug | WS016, oral, once daily for 11 months, starting at a dose of 12g with subsequent dose adjustments based on serum potassium levels. |
|
| Cumulative duration (in days) of serum potassium within the normal range during the maintenance phase | Maintenance phase baseline to maintenance phase Day 29 |
| Mean change from baseline in serum potassium at all time points of maintenance phase | Through 28 days maintenance phase |
| Percentage of participants with the mean serum potassium ≤5.0 mmol/L and percentage of participants with the mean serum potassium ≤5.5 mmol/L from D8 to D337 of the open-label extension phase | Open-label extension phase Days 8-337 |
| Recruiting |
| Wuhu |
| Anhui |
| 241000 |
| China |
| Investigator Site 48 | Recruiting | Chongqing | Chongqing Municipality | 404100 | China |
| Investigator Site 04 | Recruiting | Xiamen | Fujian | 361000 | China |
| Investigator Site 05 | Recruiting | Lanzhou | Gansu | 730000 | China |
| Investigator Site 07 | Recruiting | Guangzhou | Guangdong | 510000 | China |
| Investigator Site 06 | Recruiting | Zhanjiang | Guangdong | 524000 | China |
| Investigator Site 08 | Recruiting | Huizhou | Guangxi | 516000 | China |
| Investigator Site 09 | Recruiting | Nanning | Guangxi | 530000 | China |
| Investigator Site 10 | Recruiting | Nanning | Guangxi | 530000 | China |
| Investigator Site 11 | Recruiting | Guiyang | Guizhou | 550000 | China |
| Investigator Site 12 | Recruiting | Haikou | Hainan | 570100 | China |
| Investigator Site 13 | Recruiting | Shijiazhuang | Hebei | 050000 | China |
| Investigator Site 18 | Recruiting | Daqing | Heilongjiang | 163000 | China |
| Investigator Site 15 | Recruiting | Nanyang | Henan | 473000 | China |
| Investigator Site 16 | Recruiting | Nanyang | Henan | 473000 | China |
| Investigator Site 14 | Recruiting | Puyang | Henan | 457000 | China |
| Investigator Site 25 | Recruiting | Xinxiang | Henan | 453000 | China |
| Investigator Site 21 | Recruiting | Huangshi | Hubei | 435000 | China |
| Investigator Site 20 | Recruiting | Shiyan | Hubei | 442000 | China |
| Investigator Site 19 | Recruiting | Wuhan | Hubei | 430000 | China |
| Investigator Site 22 | Recruiting | Wuhan | Hubei | 430000 | China |
| Investigator Site 24 | Recruiting | Hengyang | Hunan | 421000 | China |
| Investigator Site 17 | Recruiting | Yueyang | Hunan | 414000 | China |
| Investigator Site 23 | Recruiting | Zhuzhou | Hunan | 412000 | China |
| Investigator Site 37 | Recruiting | Chifeng | Inner Mongolia | 024000 | China |
| Investigator Site 36 | Recruiting | Hohhot | Inner Mongolia | 010000 | China |
| Investigator Site 30 | Recruiting | Changzhou | Jiangsu | 213000 | China |
| Investigator Site 31 | Recruiting | Huai'an | Jiangsu | 223001 | China |
| Investigator Site 01 | Recruiting | Nanjing | Jiangsu | 210000 | China |
| Investigator Site 26 | Recruiting | Nantong | Jiangsu | 226000 | China |
| Investigator Site 27 | Recruiting | Suzhou | Jiangsu | 215000 | China |
| Investigator Site 29 | Recruiting | Yangzhou | Jiangsu | 225000 | China |
| Investigator Site 32 | Recruiting | Ganzhou | Jiangxi | 341000 | China |
| Investigator Site 33 | Recruiting | Nanchang | Jiangxi | 330000 | China |
| Investigator Site 34 | Recruiting | Shangrao | Jiangxi | 334000 | China |
| Investigator Site 35 | Recruiting | Shenyang | Liaoning | 110000 | China |
| Investigator Site 38 | Recruiting | Yinchuan | Ningxia | 750000 | China |
| Investigator Site 42 | Recruiting | Xi'an | Shaanxi | 710000 | China |
| Investigator Site 43 | Recruiting | Xi'an | Shaanxi | 710000 | China |
| Investigator Site 41 | Recruiting | Jinan | Shandong | 250000 | China |
| Investigator Site 40 | Recruiting | Qingdao | Shandong | 266000 | China |
| Investigator Site 39 | Recruiting | Tancheng | Shandong | 276100 | China |
| Investigator Site 44 | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
| Investigator Site 45 | Recruiting | Chengdu | Sichuan | 610000 | China |
| Investigator Site 47 | Recruiting | Chengdu | Sichuan | 610000 | China |
| Investigator Site 46 | Recruiting | Deyang | Sichuan | 618000 | China |
| Investigator Site 49 | Recruiting | Zigong | Sichuan | 643000 | China |
| Investigator Site 28 | Recruiting | Jiaxing | Zhejiang | 314000 | China |
| Investigator Site 50 | Recruiting | Wenzhou | Zhejiang | 325000 | China |
| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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