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The goal of this clinical trial is to evaluate the efficacy of different doses of WS016(3g, 6g and 12g) orally administered three times a day for 48 hours (acute treatment phase) vs placebo in the treatment of hyperkalemia, and to evaluate the efficacy of WS016(3g, 6g and 12g) orally administered once daily for 12 days ( maintenance treatment phase) vs placebo in maintaining normokalemia in participants have returned to normokalemia after the acute treatment phase.
The study plan includes approximately 140 participants who will be randomly assigned to the WS016 and placebo treatment groups. Participants will begin a 48-hour acute treatment phase with three times-daily oral administrations. After the 48-hour acute treatment, participants have returned to normokalemia will be randomly assigned again to enter a 12-day maintenance treatment phase with once-daily oral administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WS016 3g | Experimental |
| |
| WS016 6g | Experimental |
| |
| WS016 12g | Experimental |
| |
| Matching Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WS016 3g | Drug | Acute treatment phase: WS016, oral, 3g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 3g, once daily for 12 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exponential rate of change in serum potassium(S-K) levels during the acute treatment phase | Through the initial 48-hour acute treatment phase (from baseline to hour 48) | |
| Exponential rate of change in S-K levels during the maintenance treatment phase | Through 12 days of maintenance treatment phase (from Day 3 to Day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in S-K levels during the acute treatment phase | The mean change in S-K levels during the acute treatment phase compared to baseline | Through the initial 48-hour acute treatment phase |
| Proportion of participants recover from hyperkalemia |
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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 |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| WS016 6g | Drug | Acute treatment phase: WS016, oral, 6g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 6g, once daily for 12 days. |
|
| WS016 12g | Drug | Acute treatment phase: WS016, oral, 12g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 12g, once daily for 12 days. |
|
| Matching Placebo | Drug | Acute treatment phase: Matching Placebo, oral, three times a day for 48 hours; Maintenance treatment phase: Matching Placebo, oral, once daily for 12 days. |
|
The percentage of participants whose S-K levels return to normal during the acute treatment phase
| Through the initial 48-hour acute treatment phase |
| Time to normalization in S-K levels | The time(hours) it takes for participants' S-K levels to return to normal during the acute treatment phase | Through the initial 48-hour acute treatment phase |
| Proportion of patients remaining normokalemic | The percentage of participants whose S-K levels remain within the normal range (3.5-5.0 mmol/L) at the end of the maintenance treatment phase | Day 15 |
| Mean change in S-K levels during the maintenance treatment phase | The mean change in S-K levels during the maintenance treatment phase compared to baseline | Through 12 days of maintenance treatment phase (from Day 3 to Day 15) |
| Peking University Shougang Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
|
| Zhongshan Hospital, Xiamen University | Recruiting | Xiamen | Fujian | 361000 | China |
|
| The Affiliated Hospital of Hebei University | Recruiting | Baoding | Hebei | 071000 | China |
|
| Hebei Traditional Chinese Medicine Hospital | Recruiting | Shijiazhuang | Hebei | 050000 | China |
|
| The Second Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
|
| The First Hospital of Qiqihar | Recruiting | Qiqihar | Heilongjiang | 161000 | China |
|
| The First People's Hospital of Nanyang City | Recruiting | Nanyang | Henan | 473000 | China |
|
| Puyang Oilfield General Hospital | Recruiting | Puyang | Henan | 457000 | China |
|
| Shiyan Taihe Hospital | Recruiting | Shiyan | Hubei | 442000 | China |
|
| Wuhan No.4 Hospital | Recruiting | Wuhan | Hubei | 430000 | China |
|
| Zhuzhou Central Hospital | Recruiting | Zhuzhou | Hunan | 412000 | China |
|
| Affiliated Hospital of Inner Mongolia Medical University | Recruiting | Hohhot | Inner Mongolia | 010000 | China |
|
| Sir Run Run Hospital, Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| The Second Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| The Affiliated Hospital of Nantong University | Recruiting | Nantong | Jiangsu | 226000 | China |
|
| Shenyang Central Hospital, affiliated to Shenyang Medical College | Recruiting | Shenyang | Liaoning | 110000 | China |
|
| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | Ningxia | 750000 | China |
|
| The First People's Hospital of Tancheng County | Recruiting | Linyi | Shandong | 276100 | China |
|
| Qilu Hospital of Shandong University (Qingdao) | Recruiting | Qingdao | Shandong | 266000 | China |
|
| Minhang District Central Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Shanghai First People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Shanghai No.5 Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Shanghai Tongji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| The Second Affiliated Hospital of Tianjin Medical University | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| Tianjin People's Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
|
| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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