| Primary | Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). | The least squares means (LSMeans) are dervied from a mixed effects model of serial log transformed S-K values between Days 8 and 29 with patients as a random effect and the following fixed effects terms: MP treatment group; AP baseline eGFR; AP and MP baseline S-K levels, age categories (<55, 55-64, >= 65 years); and binary indicators for RAAS inhibitors use, CKD, CHF, and DM. The LSmeans estimate obtained from the above model is back-transformed and presented as the lsmeans of all available S-K values during the Maintenance phase study Days 8 to 29. | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized patients who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Posted | | Least Squares Mean | 95% Confidence Interval | mmol/L | | 22 Days; Maintenance Phase Days 8 - 29, inclusive. | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator (Maintenance Phase) | Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive. | | OG001 | ZS 5 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG002 | ZS 10 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG003 | ZS 15 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 15 g, once daily, orally as a suspension between Day 8 to 29, inclusive. |
| | Units | Counts |
|---|
| Participants | - OG00082
- OG00145
- OG00250
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0005.0603(4.9646 to 5.1578)
- OG0014.7544(4.6350 to 4.8769)
- OG0024.5081(4.4005 to 4.6184)
- OG003
|
|
| |
| Secondary | The Number of Normokalemic Days Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT). | The number of normokalemic days during the Maintenance Phase Study Days 8 to 29 is calculated assuming that the interval between assessments is normokalemic only if both the beginning and end assessments for that time interval display normal S-K values (i.e. 3.5 - 5.0 mmol/L) | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized patients who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Posted | | Mean | Standard Deviation | Days | | 22 days; Maintenance Phase Day 8 - 29, inclusive. | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator (Maintenance Phase) | Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive. | | OG001 | ZS 5 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG002 | ZS 10 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | |
|
| Secondary | Mean Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit . | | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Posted | | Mean | Standard Deviation | mmol/L | | Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive. | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator (Maintenance Phase) | Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive. | | OG001 | ZS 5 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG002 | ZS 10 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG003 | ZS 15 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 15 g, once daily, orally as a suspension between Day 8 to 29, inclusive. |
|
| Secondary | Mean Percent Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit, Inclusive . | | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Posted | | Mean | Standard Deviation | Percent Change | | Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive. | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator (Maintenance Phase) | Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive. | | OG001 | ZS 5 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG002 | ZS 10 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG003 | ZS 15 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 15 g, once daily, orally as a suspension between Day 8 to 29, inclusive. |
|
| Secondary | Mean Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit. | | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Posted | | Mean | Standard Deviation | mmol/L | | Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive. | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator (Maintenance Phase) | Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive. | | OG001 | ZS 5 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG002 | ZS 10 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG003 | ZS 15 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 15 g, once daily, orally as a suspension between Day 8 to 29, inclusive. |
|
| Secondary | Mean Percent Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit. | | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Posted | | Mean | Standard Deviation | Percent Change | | Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive. | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator (Maintenance Phase) | Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive. | | OG001 | ZS 5 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG002 | ZS 10 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG003 | ZS 15 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 15 g, once daily, orally as a suspension between Day 8 to 29, inclusive. |
|
| Secondary | Median Time to Hyperkalemia (S-K ≥ 5.1mmol/L) | | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Posted | | Median | 95% Confidence Interval | Days | | Maintenance Phase baseline to maintenance Phase Study Day 29/Exit. | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator (Maintenance Phase) | Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive. | | OG001 | ZS 5 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG002 | ZS 10 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG003 | ZS 15 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 15 g, once daily, orally as a suspension between Day 8 to 29, inclusive. |
|
| Secondary | Mean S-K Intra-subject Standard Deviation Calculated Among Subjects With ≥ 2 Values on or After Maintenance Phase Study Day 8 | | Maintenance Phase Intent- to-Treat (ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Day 8. | Posted | | Mean | 95% Confidence Interval | mmol/L | | 22 days; Maintenance Phase Day 8 - 29 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator (Maintenance Phase) | Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive. | | OG001 | ZS 5 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG002 | ZS 10 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG003 | ZS 15 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 15 g, once daily, orally as a suspension between Day 8 to 29, inclusive. |
|
| Secondary | Proportion of Subjects Who Remained Normokalemic During Maintenance Phase | | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Posted | | Number | | Proportion of subjects | | Maintenance Phase Study Days 1, 2, 5, 8, 12, 15, 19, 22, 26, 29, and 35, inclusive. | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator (Maintenance Phase) | Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive. | | OG001 | ZS 5 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG002 | ZS 10 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG003 | ZS 15 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 15 g, once daily, orally as a suspension between Day 8 to 29, inclusive. |
|
| Secondary | Median Time to Relapse in S-K Values | Median time to relapse in S-K values (return to original Acute Phase S-K baseline value) | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Posted | | Median | 95% Confidence Interval | Days | | Maintenance phase Study Day 1 to Study Day 29/Exit. | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator (Maintenance Phase) | Placebo to mimic doses of experimental drug once daily between Days 8 to 29, inclusive. | | OG001 | ZS 5 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 5 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG002 | ZS 10 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 10 g, once daily, orally as a suspension between Days 8 to 29, inclusive. | | OG003 | ZS 15 g Once Daily (Maintenance Phase) | Sodium zirconium cyclosilicate (ZS) 15 g, once daily, orally as a suspension between Day 8 to 29, inclusive. |
|
| Secondary | Exponential Rate of Change in S-K Values During the Acute Phase at 24 Hours and 48 Hours of Study Drug Treatment. | | Acute Phase ITT Population included all subjects who received at least 1 Acute Phase dose and had any post-baseline S-K levels after receiving the investigational product during the first 48 hours. | Posted | | Mean | Standard Error | log(mmol/L/hour) | | Acute Phase 24 hours and Acute Phase 48 hours. | | | | ID | Title | Description |
|---|
| OG000 | Acute Phase: ZS 10 g TID | ZS (sodium zirconium cyclosilicate) 10 g, three times a day, orally as suspension in water for 48 hours. |
| |
| Secondary | Mean Change From Baseline in S-K Values (Blood) at All Measured Time Intervals Post Dose Acute Phase. | | Acute Phase ITT Population included all subjects who received at least 1 Acute Phase dose and had any post-baseline S-K levels after receiving the investigational product during the first 48 hours. | Posted | | Mean | Standard Deviation | mmol/L | | All measured time intervals post dose during the Acute Phase. | | | | ID | Title | Description |
|---|
| OG000 | Acute Phase: ZS 10 g TID | ZS (sodium zirconium cyclosilicate) 10 g, three times a day, orally as suspension in water for 48 hours. |
| |
| Secondary | Mean Percent Change From Baseline in S-K Values (Blood) at All Measured Time Intervals Post Dose Acute Phase. | | Acute Phase ITT Population included all subjects who received at least 1 Acute Phase dose and had any post-baseline S-K levels after receiving the investigational product during the first 48 hours. | Posted | | Mean | Standard Deviation | Percent Change | | All measured time intervals post dose during the Acute Phase. | | | | ID | Title | Description |
|---|
| OG000 | Acute Phase: ZS 10 g TID | ZS (sodium zirconium cyclosilicate) 10 g, three times a day, orally as suspension in water for 48 hours. |
| |
| Secondary | Proportion of Subjects Who Achieve Normokalemia During the Acute Phase at 24 and 48 Hours After Start of Dosing | | Acute Phase ITT Population included all subjects who received at least 1 Acute Phase dose and had any post-baseline S-K levels after receiving the investigational product during the first 48 hours. | Posted | | Number | | Proportion of subjects | | Through 48 hours acute phase | | | | ID | Title | Description |
|---|
| OG000 | Acute Phase: ZS 10 g TID | ZS (sodium zirconium cyclosilicate) 10 g, three times a day, orally as suspension in water for 48 hours. |
| | |
| Secondary | Median Time to Normalization (3.50-5.0 mmol/L) in S-K Levels in the 48 Hours of Initial Treatment | | Acute Phase ITT Population included all subjects who received at least 1 Acute Phase dose and had any post-baseline S-K levels after receiving the investigational product during the first 48 hours. | Posted | | Median | 95% Confidence Interval | Hours | | Through 48 hours acute phase | | | | ID | Title | Description |
|---|
| OG000 | Acute Phase: ZS 10 g TID | ZS (sodium zirconium cyclosilicate) 10 g, three times a day, orally as a suspension for 48 hours. |
| | |