| Primary | Difference in the Exponential Rate of Change in Serum Potassium (S-K) Levels Versus Placebo During the Initial 48 Hours of Study Drug Treatment | The rate of fall in S-K levels during the initial 48 hours of study drug treatment between the placebo treated subjects and the ZS treated subjects measured on a log scale | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Error | log(mmol/L/hour) | | 24 and 48 hours post first study drug dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Sodium Zirconium Cyclosilicate 3 g Three Times Daily | Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | Sodium zirconium cyclosilicate 10 g three times daily, orally as a suspension in water |
| | Units | Counts |
|---|
| Participants | - OG00030
- OG00112
- OG00224
- OG003
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| | Title | Denominators | Categories |
|---|
| Day2/0 Hr ( 24 hours) | | | Title | Measurements |
|---|
| - OG0000± NAA consequence of the modeling estimate when control is the reference standard
- OG001-0.00035± 0.001166
- OG002-0.00169± 0.000932
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| Secondary | Serum Potassium (S-K) at Individual Time Points. | Serum potassium (S-K) at individual time points through Study day 3/0hour. | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Deviation | mmol/L | | First 48 hours of study | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Sodium Zirconium Cyclosilicate 3 g Three Times Daily | Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | Sodium zirconium cyclosilicate 10 g three times daily, orally as a suspension in water |
|
| Secondary | Time Specific S-K Levels to Normalization | Percent of subjects achieving S-K normalization (<=as defined by S-K levels of 3.5 to 4.9 mmol/L) from baseline at Study Days 2 and 3 at 0 hr. | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Number | | percentage of participants | | 48 and 72 hours post first study drug dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Sodium Zirconium Cyclosilicate 3 g Three Times Daily | Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | |
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| Secondary | Time Specific Decreases in S-K Levels of > = 0.5 mmol/L | Percentage of participants achieving a 0.5mmol/L drop from baseline at Study Days 2 and 3 at 0 hr. | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Number | | percentage of participants | | 24 and 48 hours post first study drug dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Sodium Zirconium Cyclosilicate 3 g Three Times Daily | Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | Sodium zirconium cyclosilicate 10 g three times daily, orally as a suspension in water |
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| Secondary | Percentage of Participants With Normal S-K Levels at End of Study Day 2 | Percentage (%) of subjects who achieve S-K normalization at end of Study Day 2 | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Number | | percentage of participants | | 48 hours post first study drug dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Sodium Zirconium Cyclosilicate 3 g Three Times Daily | Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | Sodium zirconium cyclosilicate 10 g three times daily, orally as a suspension in water |
|
| Secondary | Urine Sodium Excretion | Urine sodium excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2). | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Deviation | mmol/L | | 24 and 48 hours post first study drug dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Sodium Zirconium Cyclosilicate 3 g Three Times Daily | Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | |
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| Secondary | Urine Potassium Excretion | Urine potassium excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2). | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Deviation | mmol/L | | 24 and 48 hours post study drug dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Sodium Zirconium Cyclosilicate 3 g Three Times Daily | Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | |
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| Secondary | Urea Nitrogen Excretion | Urea nitrogen excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2). | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Deviation | mg/dL | | 24 and 48 hours post study drug dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Sodium Zirconium Cyclosilicate 3 g Three Times Daily | Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | |
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| Secondary | Blood Urea Nitrogen | Blood urea nitrogen compared between the combined placebo-treated controls and the ZS-treated subjects (measured 24 & 48 hours post dose on Study Days 2 and 3). | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Deviation | mg/dL | | 24 and 48 hours post study drug dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Sodium Zirconium Cyclosilicate 3 g Three Times Daily | Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | |
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| Secondary | Serum Magnesium (S-Mg) Levels | Serum magnesium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 & 48 hours post dose on Study Days 2 and 3). | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Deviation | mg/dL | | 24 and 48 hours post study drug dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Sodium Zirconium Cyclosilicate 3 g Three Times Daily | Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | |
|
| Secondary | Serum Calcium (S-Ca) Levels | Serum calcium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 & 48 hours post dose on Study Days 2 and 3). | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Deviation | mg/dL | | 24 and 48 hours post study drug dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Sodium Zirconium Cyclosilicate 3 g Three Times Daily | Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | |
|
| Secondary | Serum Sodium (S-Na) Levels | Serum sodium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 & 48 hours post dose on Study Days 2 and 3). | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Deviation | mmol/L | | 24 and 48 hours post study drug dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Sodium Zirconium Cyclosilicate 3 g Three Times Daily | Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | |
|
| Secondary | Serum Bicarbonate (HCO3) Levels | Serum bicarbonate compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 & 48 hours post dose on Study Days 2 and 3). | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Deviation | mmol/L | | 24 and 48 hours post study drug dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Zirconium Silicate 3 g Three Times Daily | Zirconium Silicate (ZS) 3 g TID, three times daily as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | |
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| Secondary | 24-hour Urinary Excretion of Potassium | 24-hour urinary excretion of potassium on Study Days 1 and Day 2 | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Deviation | mmol/24 hour | | 24 and 48 hours post study drug dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Zirconium Silicate 3 g Three Times Daily | Zirconium Silicate (ZS) 3 g TID, three times daily as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | Sodium zirconium cyclosilicate 10 g three times daily, orally as a suspension in water |
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| Secondary | 24-hour Urinary Excretion of Sodium | 24-hour urinary excretion of sodium on Study Days 1 and Day 2 | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Deviation | mmol/24 hour | | 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Zirconium Silicate 3 g Three Times Daily | Zirconium Silicate (ZS) 3 g TID, three times daily as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | Sodium zirconium cyclosilicate 10 g three times daily, orally as a suspension in water |
|
| Secondary | 24-hour Urinary Excretion of Urea Nitrogen | 24-hour urinary excretion of urea nitrogen on Study Days 1 and Day 2 | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Deviation | g/24 hour | | 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Zirconium Silicate 3 g Three Times Daily | Zirconium Silicate (ZS) 3 g TID, three times daily as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | Sodium zirconium cyclosilicate 10 g three times daily, orally as a suspension in water |
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| Secondary | 24-hour Urinary Excretion of Creatinine | 24-hour urinary excretion of creatinine on Study Days 1 and Day 2 | Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours. | Posted | | Mean | Standard Deviation | mg/24 hour | | 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Combined All Three Cohorts) | Placebo randomized to mimic escalating doses of experimental drug administered three times a day (TID). | | OG001 | Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily | Sodium zirconium cyclosilicate 0.3 g three times daily, orally as a suspension in water | | OG002 | Sodium Zirconium Cyclosilicate 3 g Three Times Daily | Sodium zirconium cyclosilicate 3 g three times daily, orally as a suspension in water | | OG003 | Sodium Zirconium Cyclosilicate 10 g Three Times Daily | Sodium zirconium cyclosilicate 10 g three times daily, orally as a suspension in water |
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