Hyperkalemia
Conditions
Brief summary
Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 - 6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis). Subacute Phase (randomized withdrawal): It is hypothesized that ZS once daily is more effective than placebo control (alternative hypotheses) in maintaining normokalemic levels (3.5 - 4.9 mmol/l) among subjects completing the Acute Phase versus no difference between each ZS dose and respective placebo controls (null hypotheses).
Detailed description
A total of 750 subjects with mild to moderate hyperkalemia (i- STAT potassium levels between 5.0-6.5 mmol/l, inclusive) will be enrolled in the study where they, in a double-blind fashion, will be randomized 1:1:1:1:1 to receive one of four (4) doses of ZS (1.25g, 2.5g, 5g, and 10g) or placebo control, administered 3 times daily (tid) with meals for the initial 48 hours (Acute Phase), followed by a Subacute Phase (randomized withdrawal) during which patients treated with active doses in the Acute Phase, who achieve normokalemia (i-STAT potassium values 3.5 to 4.9 mmol/l, inclusive) will be randomized to 12 days of subacute, once a day (qd) dosing. There will be a one-time randomization to assign the Acute Phase treatment and the Subacute Phase treatment. The Subacute Phase will include subjects who became normokalemic on active drug and those who became normokalemic on placebo. The former will be randomized in a 1:1 ratio between the same dose of ZS they received during the acute phase but only administered once a day (qd) or placebo, qd. Subjects on placebo during the Acute Phase who are normokalemic in the morning of Study Day 3, will be randomized to receive either 1.25 or 2.5 g ZS, qd as Subacute Phase treatment. Safety and tolerability will be assessed on an ongoing basis by an Independent Data Safety Monitoring Board (DSMB). Each active dose group will consist of 150 patients per treatment group including the placebo control group for a total of 750 patients; the 1:1:1:1:1 allocation helps to optimize the multiple active dose comparisons to the respective placebo controls for the Subacute Phase.
Interventions
DRUGZirconium silicate (acute phase)
Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered 3 times (tid) daily with meals for 48 hours.
DRUGZirconium silicate (subacute phase)
Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered once a day prior to the morning meal for 12 days.
DRUGPlacebo (acute phase)
Randomized to mimic doses of experimental drug administered 3 times (tid) daily with meals for 48 hours during the acute phase.
DRUGPlacebo ( subacute phase)
Randomized to mimic doses of experimental drug administered once a day prior to the morning meal for 12 days during the subacute phase.
Sponsors
ZS Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent. * Over 18 years of age. * Mean i-STAT potassium values between 5.0 - 6.5 mmol/l inclusive, at screening (Study Day 0). * Ability to have repeated blood draws or effective venous catheterization. * Women of childbearing potential must be practicing a highly effective method of birth control.
Exclusion criteria
* Pseudohyperkalemia signs and symptoms, such as excessive fist clinching hemolyzed blood specimen, severe leukocytosis or thrombocytosis. * Subjects treated with lactulose, xifaxan or other nonabsorbed antibiotics for hyperammonemia within the last 7 days. * Subjects treated with resins (such as Sevelamer acetate or Sodium polystyrene sulfonate \[SPS; e.g. Kayexalate®\]), calcium acetate, calcium carbonate, or lanthanum carbonate, within the last 7 days. * Subjects with a life expectancy of less than 3 months. * Subjects who are HIV positive. * Subjects who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the subjects' tasks associated with the protocol. * Women who are pregnant, lactating, or planning to become pregnant. * Subjects with Ketoacidosis/Acidemia. * Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated. * Known hypersensitivity or previous anaphylaxis to ZS or to components thereof. * Previous treatment with ZS * Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry. * Subjects with cardiac arrhythmias that require immediate treatment. * Insulin-dependent diabetes mellitus * Subjects on dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Through 48 hours acute phase |
| Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through 12 days subacute phase (Day 3 through Day 15) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Through 48 hours acute phase. In particular, 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3. | Mean percent change from baseline in S-K at all time points over initial 48 hours |
| Time Subjects Remain Normokalemic (Subacute Phase) | Through 18 days (12 days treatment, 6 days follow-up) of subacute phase | Time (number of days) subjects remain normokalemic (3.5 - 5.0 mmol/l) subacute phase |
| Percentage of Subjects Who Achieve Normalization in S-K Levels After 48 Hours of Treatment | Through 48 hours acute phase | — |
| Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Through 18 days of subacute phase (12 days treatment, 6 days follow-up) | Mean change from subacute baseline in serum potassium at all time points during subacute phase |
| Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Through 18 days of subacute phase (12 days treatment, 6 days follow-up) | Mean percent change from subacute baseline in serum potassium at all time points during subacute phase |
| Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase | Through 18 days of subacute phase (12 days treatment, 6 days follow-up) | Percentage of subjects within each treatment group who retained normal S-K values (values between 3.5-5.0 mmol/L) at end of subacute phase |
| Mean Change From Baseline in S-K at All Time Points Acute Phase | Through 48 hours acute phase. In particular, at Baseline; 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3. | Mean change from baseline in S-K at all time points over initial 48 hours |
Countries
Australia, United States
Participant flow
Recruitment details
Participants took part in the study at 65 sites (up to 100 sites initially planned in Protocol) in the United States, Australia, and South Africa from 25 November 2012 to 29 October 2013.
Pre-assignment details
In the acute phase, 754 subjects were randomized; 753 were treated. Subjects who completed the AP and had i-STAT K+ values within normal range in a.m. of Study Day 3 could enter the Subacute Phase. 543 subjects entered the subacute phase.
Participants by arm
| Arm | Count |
|---|---|
| Acute Phase: Placebo TID Participants administered placebo three times daily (TID) orally as suspension for first 48 hours. | 158 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID Participants administered ZS 1.25 g TID as suspension orally for first 48 hours. | 154 |
| Acute Phase: ZS 2.5 g TID Participants administered ZS 2.5 g TID as suspension orally for first 48 hours. | 141 |
| Acute Phase: ZS 5 g TID Participants administered ZS 5 g TID as suspension orally for first 48 hours. | 157 |
| Acute Phase: ZS 10 TID Participants administered ZS 10 g TID as suspension orally for first 48 hours. | 143 |
| Total | 753 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acute Phase-Initial 48 Hours | Adverse Event | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Acute Phase-Initial 48 Hours | Family emergency | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Acute Phase-Initial 48 Hours | hypo-or hyperkalemia | 1 | 1 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Acute Phase-Initial 48 Hours | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Acute Phase-Initial 48 Hours | Sponsor's decision | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Acute Phase-Initial 48 Hours | Withdrawal by Subject | 0 | 1 | 1 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Subacute Phase | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 4 | 1 | 1 | 0 | 0 |
| Subacute Phase | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Subacute Phase | Hypo-or hyperkalemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Subacute Phase | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Subacute Phase | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Subacute Phase | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Subacute Phase | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 1 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Acute Phase: ZS 2.5 g TID | Acute Phase: ZS 5 g TID | Acute Phase: ZS 10 TID | Total | Acute Phase: Placebo TID |
|---|---|---|---|---|---|---|
| Acute S-K baseline ≤ 5.3 mmol/L | 76 Participants | 72 Participants | 90 Participants | 94 Participants | 427 Participants | 95 Participants |
| Acute S-K baseline 5.4-5.5 mmol/L | 38 Participants | 29 Participants | 36 Participants | 27 Participants | 152 Participants | 22 Participants |
| Acute S-K baseline > 5.5 mmol/L | 40 Participants | 40 Participants | 31 Participants | 22 Participants | 174 Participants | 41 Participants |
| Age, Customized Acute Phase | 65.4 Years STANDARD_DEVIATION 13.07 | 65.9 Years STANDARD_DEVIATION 11.73 | 65.2 Years STANDARD_DEVIATION 11.91 | 66.2 Years STANDARD_DEVIATION 12.16 | 65.6 Years STANDARD_DEVIATION 12.24 | 65.6 Years STANDARD_DEVIATION 12.24 |
| Baseline eGFR 15-29+ ml/min | 42 Participants | 38 Participants | 43 Participants | 42 Participants | 209 Participants | 44 Participants |
| Baseline eGFR <15 ml/min | 8 Participants | 15 Participants | 8 Participants | 10 Participants | 56 Participants | 15 Participants |
| Baseline eGFR 30-59+ mL/min | 73 Participants | 48 Participants | 64 Participants | 50 Participants | 296 Participants | 61 Participants |
| Baseline eGFR ≥60 mL/min | 28 Participants | 37 Participants | 39 Participants | 41 Participants | 183 Participants | 38 Participants |
| Etiology of elevated S-K Chronic kidney disease | 102 Participants | 89 Participants | 93 Participants | 83 Participants | 463 Participants | 96 Participants |
| Etiology of elevated S-K Congestive heart failure | 57 Participants | 54 Participants | 64 Participants | 59 Participants | 300 Participants | 66 Participants |
| Etiology of elevated S-K Diabetes mellitus | 94 Participants | 84 Participants | 96 Participants | 81 Participants | 451 Participants | 96 Participants |
| Etiology of elevated S-K RAAS inhibitor medication | 109 Participants | 97 Participants | 99 Participants | 96 Participants | 502 Participants | 101 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 5 Participants | 3 Participants | 2 Participants | 12 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 20 Participants | 11 Participants | 20 Participants | 19 Participants | 87 Participants | 17 Participants |
| Race/Ethnicity, Customized Multiple Races | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 131 Participants | 125 Participants | 132 Participants | 120 Participants | 644 Participants | 136 Participants |
| Sex/Gender, Customized Female | 71 Participants | 50 Participants | 61 Participants | 63 Participants | 305 Participants | 60 Participants |
| Sex/Gender, Customized Male | 83 Participants | 91 Participants | 96 Participants | 80 Participants | 448 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 158 | 18 / 154 | 6 / 141 | 6 / 157 | 10 / 143 | 14 / 41 | 10 / 49 | 7 / 46 | 13 / 54 | 12 / 68 | 14 / 65 | 6 / 61 | 16 / 63 | 8 / 46 | 6 / 50 |
| serious Total, serious adverse events | 1 / 158 | 0 / 154 | 0 / 141 | 0 / 157 | 0 / 143 | 1 / 41 | 2 / 49 | 1 / 46 | 2 / 54 | 2 / 68 | 3 / 65 | 1 / 61 | 1 / 63 | 1 / 46 | 1 / 50 |
Outcome results
Primary
Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment.
Time frame: Through 48 hours acute phase
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Phase: Placebo TID | Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Through 24 Hours | -0.00128 log(mmol/L)/hour | Standard Error 0.000243 |
| Acute Phase: Placebo TID | Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Through 48 Hours | -0.00097 log(mmol/L)/hour | Standard Error 0.000137 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Through 24 Hours | -0.00187 log(mmol/L)/hour | Standard Error 0.00025 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Through 48 Hours | -0.00110 log(mmol/L)/hour | Standard Error 0.000141 |
| Acute Phase: ZS 2.5 g TID | Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Through 24 Hours | -0.00205 log(mmol/L)/hour | Standard Error 0.000263 |
| Acute Phase: ZS 2.5 g TID | Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Through 48 Hours | -0.00163 log(mmol/L)/hour | Standard Error 0.000148 |
| Acute Phase: ZS 5 g TID | Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Through 48 Hours | -0.00223 log(mmol/L)/hour | Standard Error 0.000141 |
| Acute Phase: ZS 5 g TID | Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Through 24 Hours | -0.00280 log(mmol/L)/hour | Standard Error 0.00025 |
| Acute Phase: ZS 10 g TID | Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Through 24 Hours | -0.00382 log(mmol/L)/hour | Standard Error 0.000258 |
| Acute Phase: ZS 10 g TID | Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Through 48 Hours | -0.00321 log(mmol/L)/hour | Standard Error 0.000145 |
Primary
Exponential Rate of Change in S-K Levels in the Subacute Phase.
Time frame: Through 12 days subacute phase (Day 3 through Day 15)
Population: ITT population. One subject in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Phase: Placebo TID | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 8 | 0.00054 log(mmol/L)/hour | Standard Error 0.004803 |
| Acute Phase: Placebo TID | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 15 | 0.00085 log(mmol/L)/hour | Standard Error 0.001089 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 8 | 0.00874 log(mmol/L)/hour | Standard Error 0.004308 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 15 | 0.00198 log(mmol/L)/hour | Standard Error 0.000959 |
| Acute Phase: ZS 2.5 g TID | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 8 | 0.01104 log(mmol/L)/hour | Standard Error 0.004123 |
| Acute Phase: ZS 2.5 g TID | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 15 | 0.00206 log(mmol/L)/hour | Standard Error 0.001189 |
| Acute Phase: ZS 5 g TID | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 8 | 0.00734 log(mmol/L)/hour | Standard Error 0.003642 |
| Acute Phase: ZS 5 g TID | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 15 | 0.00237 log(mmol/L)/hour | Standard Error 0.001049 |
| Acute Phase: ZS 10 g TID | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 15 | 0.00457 log(mmol/L)/hour | Standard Error 0.001007 |
| Acute Phase: ZS 10 g TID | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 8 | 0.01441 log(mmol/L)/hour | Standard Error 0.003776 |
| Subacute Phase: ZS 5 g QD | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 15 | 0.00089 log(mmol/L)/hour | Standard Error 0.001049 |
| Subacute Phase: ZS 5 g QD | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 8 | 0.00581 log(mmol/L)/hour | Standard Error 0.003918 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 15 | 0.00979 log(mmol/L)/hour | Standard Error 0.001115 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 8 | 0.02469 log(mmol/L)/hour | Standard Error 0.003939 |
| Subacute Phase: ZS 10 g QD | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 8 | -0.00053 log(mmol/L)/hour | Standard Error 0.003877 |
| Subacute Phase: ZS 10 g QD | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 15 | 0.00136 log(mmol/L)/hour | Standard Error 0.001097 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 8 | 0.00643 log(mmol/L)/hour | Standard Error 0.004171 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 15 | -0.00098 log(mmol/L)/hour | Standard Error 0.001054 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 8 | 0.00390 log(mmol/L)/hour | Standard Error 0.004023 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through Day 15 | 0.00023 log(mmol/L)/hour | Standard Error 0.001004 |
Secondary
Mean Change From Baseline in S-K at All Time Points Acute Phase
Mean change from baseline in S-K at all time points over initial 48 hours
Time frame: Through 48 hours acute phase. In particular, at Baseline; 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3.
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Phase: Placebo TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Baseline, mean | 5.30 mmol/L | Standard Deviation 0.365 |
| Acute Phase: Placebo TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 1 hour Post 1st Dose | 0.01 mmol/L | Standard Deviation 0.404 |
| Acute Phase: Placebo TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 2 hour Post 1st Dose | 0.00 mmol/L | Standard Deviation 0.423 |
| Acute Phase: Placebo TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 4 hour Post 1st Dose | -0.22 mmol/L | Standard Deviation 0.429 |
| Acute Phase: Placebo TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 0 hour Pre-dose | -0.18 mmol/L | Standard Deviation 0.363 |
| Acute Phase: Placebo TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 1 hour Post 1st Dose | -0.24 mmol/L | Standard Deviation 0.484 |
| Acute Phase: Placebo TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 4 hour Post 1st Dose | -0.22 mmol/L | Standard Deviation 0.44 |
| Acute Phase: Placebo TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 3: 0 hour Pre-dose | -0.25 mmol/L | Standard Deviation 0.413 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 2 hour Post 1st Dose | -0.04 mmol/L | Standard Deviation 0.366 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 1 hour Post 1st Dose | -0.27 mmol/L | Standard Deviation 0.415 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Baseline, mean | 5.37 mmol/L | Standard Deviation 0.369 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 4 hour Post 1st Dose | -0.28 mmol/L | Standard Deviation 0.425 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 1 hour Post 1st Dose | -0.01 mmol/L | Standard Deviation 0.36 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 3: 0 hour Pre-dose | -0.30 mmol/L | Standard Deviation 0.404 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 0 hour Pre-dose | -0.28 mmol/L | Standard Deviation 0.393 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 4 hour Post 1st Dose | -0.32 mmol/L | Standard Deviation 0.449 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 4 hour Post 1st Dose | -0.40 mmol/L | Standard Deviation 0.462 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 3: 0 hour Pre-dose | -0.46 mmol/L | Standard Deviation 0.398 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 4 hour Post 1st Dose | -0.34 mmol/L | Standard Deviation 0.409 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 1 hour Post 1st Dose | -0.38 mmol/L | Standard Deviation 0.479 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 2 hour Post 1st Dose | -0.06 mmol/L | Standard Deviation 0.499 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 1 hour Post 1st Dose | -0.08 mmol/L | Standard Deviation 0.394 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Baseline, mean | 5.35 mmol/L | Standard Deviation 0.4 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 0 hour Pre-dose | -0.32 mmol/L | Standard Deviation 0.39 |
| Acute Phase: ZS 5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 1 hour Post 1st Dose | -0.06 mmol/L | Standard Deviation 0.413 |
| Acute Phase: ZS 5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 2 hour Post 1st Dose | -0.09 mmol/L | Standard Deviation 0.355 |
| Acute Phase: ZS 5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 4 hour Post 1st Dose | -0.31 mmol/L | Standard Deviation 0.389 |
| Acute Phase: ZS 5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 0 hour Pre-dose | -0.40 mmol/L | Standard Deviation 0.375 |
| Acute Phase: ZS 5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 1 hour Post 1st Dose | -0.46 mmol/L | Standard Deviation 0.44 |
| Acute Phase: ZS 5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 3: 0 hour Pre-dose | -0.54 mmol/L | Standard Deviation 0.459 |
| Acute Phase: ZS 5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Baseline, mean | 5.31 mmol/L | Standard Deviation 0.337 |
| Acute Phase: ZS 5 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 4 hour Post 1st Dose | -0.47 mmol/L | Standard Deviation 0.465 |
| Acute Phase: ZS 10 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 4 hour Post 1st Dose | -0.37 mmol/L | Standard Deviation 0.445 |
| Acute Phase: ZS 10 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 3: 0 hour Pre-dose | -0.73 mmol/L | Standard Deviation 0.496 |
| Acute Phase: ZS 10 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 2 hour Post 1st Dose | -0.18 mmol/L | Standard Deviation 0.36 |
| Acute Phase: ZS 10 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 4 hour Post 1st Dose | -0.62 mmol/L | Standard Deviation 0.42 |
| Acute Phase: ZS 10 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Baseline, mean | 5.26 mmol/L | Standard Deviation 0.337 |
| Acute Phase: ZS 10 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 1 hour Post 1st Dose | -0.68 mmol/L | Standard Deviation 0.437 |
| Acute Phase: ZS 10 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 1: 1 hour Post 1st Dose | -0.11 mmol/L | Standard Deviation 0.361 |
| Acute Phase: ZS 10 g TID | Mean Change From Baseline in S-K at All Time Points Acute Phase | Study Day 2: 0 hour Pre-dose | -0.52 mmol/L | Standard Deviation 0.364 |
Secondary
Mean Change From Subacute Baseline in Serum Potassium at All Time Points.
Mean change from subacute baseline in serum potassium at all time points during subacute phase
Time frame: Through 18 days of subacute phase (12 days treatment, 6 days follow-up)
Population: ITT population. One subject (087-025) in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Phase: Placebo TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Baseline, mean | 4.81 mmol/L | Standard Deviation 0.324 |
| Acute Phase: Placebo TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 | 0.06 mmol/L | Standard Deviation 0.474 |
| Acute Phase: Placebo TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Acute Baseline, mean | 5.22 mmol/L | Standard Deviation 0.263 |
| Acute Phase: Placebo TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 | -0.06 mmol/L | Standard Deviation 0.575 |
| Acute Phase: Placebo TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 | 0.02 mmol/L | Standard Deviation 0.362 |
| Acute Phase: Placebo TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 | 0.11 mmol/L | Standard Deviation 0.385 |
| Acute Phase: Placebo TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 | 0.04 mmol/L | Standard Deviation 0.477 |
| Acute Phase: Placebo TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 | 0.04 mmol/L | Standard Deviation 0.387 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 | 0.22 mmol/L | Standard Deviation 0.459 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 | 0.07 mmol/L | Standard Deviation 0.411 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 | 0.18 mmol/L | Standard Deviation 0.368 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Baseline, mean | 4.80 mmol/L | Standard Deviation 0.391 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 | 0.11 mmol/L | Standard Deviation 0.432 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 | 0.13 mmol/L | Standard Deviation 0.405 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Acute Baseline, mean | 5.29 mmol/L | Standard Deviation 0.343 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 | 0.15 mmol/L | Standard Deviation 0.416 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Acute Baseline, mean | 5.25 mmol/L | Standard Deviation 0.268 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 | 0.09 mmol/L | Standard Deviation 0.442 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 | 0.22 mmol/L | Standard Deviation 0.532 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 | 0.18 mmol/L | Standard Deviation 0.52 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 | 0.17 mmol/L | Standard Deviation 0.431 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Baseline, mean | 4.77 mmol/L | Standard Deviation 0.349 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 | 0.21 mmol/L | Standard Deviation 0.416 |
| Acute Phase: ZS 2.5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 | 0.07 mmol/L | Standard Deviation 0.451 |
| Acute Phase: ZS 5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 | 0.18 mmol/L | Standard Deviation 0.35 |
| Acute Phase: ZS 5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 | 0.23 mmol/L | Standard Deviation 0.451 |
| Acute Phase: ZS 5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Baseline, mean | 4.66 mmol/L | Standard Deviation 0.336 |
| Acute Phase: ZS 5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 | 0.12 mmol/L | Standard Deviation 0.356 |
| Acute Phase: ZS 5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 | 0.11 mmol/L | Standard Deviation 0.329 |
| Acute Phase: ZS 5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 | 0.18 mmol/L | Standard Deviation 0.522 |
| Acute Phase: ZS 5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 | 0.05 mmol/L | Standard Deviation 0.36 |
| Acute Phase: ZS 5 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Acute Baseline, mean | 5.23 mmol/L | Standard Deviation 0.354 |
| Acute Phase: ZS 10 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 | 0.26 mmol/L | Standard Deviation 0.555 |
| Acute Phase: ZS 10 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Baseline, mean | 4.76 mmol/L | Standard Deviation 0.44 |
| Acute Phase: ZS 10 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 | 0.17 mmol/L | Standard Deviation 0.503 |
| Acute Phase: ZS 10 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 | 0.12 mmol/L | Standard Deviation 0.477 |
| Acute Phase: ZS 10 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 | 0.24 mmol/L | Standard Deviation 0.584 |
| Acute Phase: ZS 10 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Acute Baseline, mean | 5.31 mmol/L | Standard Deviation 0.302 |
| Acute Phase: ZS 10 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 | 0.07 mmol/L | Standard Deviation 0.493 |
| Acute Phase: ZS 10 g TID | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 | 0.27 mmol/L | Standard Deviation 0.56 |
| Subacute Phase: ZS 5 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 | 0.10 mmol/L | Standard Deviation 0.519 |
| Subacute Phase: ZS 5 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 | 0.30 mmol/L | Standard Deviation 0.539 |
| Subacute Phase: ZS 5 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Baseline, mean | 4.63 mmol/L | Standard Deviation 0.357 |
| Subacute Phase: ZS 5 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 | 0.12 mmol/L | Standard Deviation 0.446 |
| Subacute Phase: ZS 5 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 | 0.11 mmol/L | Standard Deviation 0.499 |
| Subacute Phase: ZS 5 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 | 0.11 mmol/L | Standard Deviation 0.51 |
| Subacute Phase: ZS 5 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Acute Baseline, mean | 5.24 mmol/L | Standard Deviation 0.325 |
| Subacute Phase: ZS 5 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 | 0.14 mmol/L | Standard Deviation 0.532 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Acute Baseline, mean | 5.24 mmol/L | Standard Deviation 0.29 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 | 0.43 mmol/L | Standard Deviation 0.467 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 | 0.58 mmol/L | Standard Deviation 0.485 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Baseline, mean | 4.42 mmol/L | Standard Deviation 0.353 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 | 0.37 mmol/L | Standard Deviation 0.426 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 | 0.13 mmol/L | Standard Deviation 0.363 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 | 0.59 mmol/L | Standard Deviation 0.504 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 | 0.28 mmol/L | Standard Deviation 0.387 |
| Subacute Phase: ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 | 0.44 mmol/L | Standard Deviation 0.652 |
| Subacute Phase: ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 | 0.00 mmol/L | Standard Deviation 0.452 |
| Subacute Phase: ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Baseline, mean | 4.52 mmol/L | Standard Deviation 0.448 |
| Subacute Phase: ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 | 0.10 mmol/L | Standard Deviation 0.573 |
| Subacute Phase: ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 | -0.06 mmol/L | Standard Deviation 0.557 |
| Subacute Phase: ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Acute Baseline, mean | 5.27 mmol/L | Standard Deviation 0.369 |
| Subacute Phase: ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 | 0.06 mmol/L | Standard Deviation 0.564 |
| Subacute Phase: ZS 10 g QD | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 | 0.00 mmol/L | Standard Deviation 0.531 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 | -0.01 mmol/L | Standard Deviation 0.438 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 | 0.09 mmol/L | Standard Deviation 0.477 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Baseline, mean | 4.81 mmol/L | Standard Deviation 0.348 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 | 0.05 mmol/L | Standard Deviation 0.373 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 | 0.07 mmol/L | Standard Deviation 0.437 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 | 0.04 mmol/L | Standard Deviation 0.409 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Acute Baseline, mean | 5.15 mmol/L | Standard Deviation 0.293 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 | 0.11 mmol/L | Standard Deviation 0.4 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 | 0.14 mmol/L | Standard Deviation 0.492 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Acute Baseline, mean | 5.19 mmol/L | Standard Deviation 0.325 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Baseline, mean | 4.80 mmol/L | Standard Deviation 0.379 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 | 0.04 mmol/L | Standard Deviation 0.362 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 | 0.12 mmol/L | Standard Deviation 0.389 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 | 0.03 mmol/L | Standard Deviation 0.501 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 | 0.13 mmol/L | Standard Deviation 0.457 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 | 0.04 mmol/L | Standard Deviation 0.451 |
Secondary
Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase
Mean percent change from baseline in S-K at all time points over initial 48 hours
Time frame: Through 48 hours acute phase. In particular, 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3.
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Phase: Placebo TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 1 hour Post 1st Dose Percent change | 0.09 percentage | Standard Deviation 7.606 |
| Acute Phase: Placebo TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 3: 0 hour Pre-dose Percent change | -4.62 percentage | Standard Deviation 7.751 |
| Acute Phase: Placebo TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 4 hour Post 1st Dose Percent change | -4.08 percentage | Standard Deviation 8.253 |
| Acute Phase: Placebo TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 4 hour Post 1st Dose Percent change | -4.05 percentage | Standard Deviation 8.021 |
| Acute Phase: Placebo TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 2 hour Post 1st Dose Percent change | 0.03 percentage | Standard Deviation 7.911 |
| Acute Phase: Placebo TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 0 hour Pre-dose Percent change | -3.40 percentage | Standard Deviation 6.819 |
| Acute Phase: Placebo TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 1 hour Post 1st Dose Percent change | -4.42 percentage | Standard Deviation 8.904 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 1 hour Post 1st Dose Percent change | -4.99 percentage | Standard Deviation 7.717 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 0 hour Pre-dose Percent change | -5.14 percentage | Standard Deviation 7.19 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 2 hour Post 1st Dose Percent change | -0.81 percentage | Standard Deviation 6.813 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 1 hour Post 1st Dose Percent change | -0.23 percentage | Standard Deviation 6.732 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 4 hour Post 1st Dose Percent change | -5.82 percentage | Standard Deviation 8.187 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 4 hour Post 1st Dose Percent change | -5.20 percentage | Standard Deviation 7.842 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 3: 0 hour Pre-dose Percent change | -5.44 percentage | Standard Deviation 7.476 |
| Acute Phase: ZS 2.5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 0 hour Pre-dose Percent change | -6.02 percentage | Standard Deviation 7.099 |
| Acute Phase: ZS 2.5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 1 hour Post 1st Dose Percent change | -1.37 percentage | Standard Deviation 7.273 |
| Acute Phase: ZS 2.5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 2 hour Post 1st Dose Percent change | -0.99 percentage | Standard Deviation 9.384 |
| Acute Phase: ZS 2.5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 4 hour Post 1st Dose Percent change | -6.34 percentage | Standard Deviation 7.46 |
| Acute Phase: ZS 2.5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 1 hour Post 1st Dose Percent change | -6.95 percentage | Standard Deviation 8.91 |
| Acute Phase: ZS 2.5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 4 hour Post 1st Dose Percent change | -7.27 percentage | Standard Deviation 8.405 |
| Acute Phase: ZS 2.5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 3: 0 hour Pre-dose Percent change | -8.48 percentage | Standard Deviation 7.291 |
| Acute Phase: ZS 5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 4 hour Post 1st Dose Percent change | -5.74 percentage | Standard Deviation 7.283 |
| Acute Phase: ZS 5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 1 hour Post 1st Dose Percent change | -8.62 percentage | Standard Deviation 8.082 |
| Acute Phase: ZS 5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 2 hour Post 1st Dose Percent change | -1.71 percentage | Standard Deviation 6.725 |
| Acute Phase: ZS 5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 3: 0 hour Pre-dose Percent change | -10.04 percentage | Standard Deviation 8.33 |
| Acute Phase: ZS 5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 4 hour Post 1st Dose Percent change | -8.63 percentage | Standard Deviation 8.541 |
| Acute Phase: ZS 5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 1 hour Post 1st Dose Percent change | -1.13 percentage | Standard Deviation 7.791 |
| Acute Phase: ZS 5 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 0 hour Pre-dose Percent change | -7.31 percentage | Standard Deviation 6.942 |
| Acute Phase: ZS 10 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 4 hour Post 1st Dose Percent change | -6.91 percentage | Standard Deviation 8.249 |
| Acute Phase: ZS 10 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 3: 0 hour Pre-dose Percent change | -13.76 percentage | Standard Deviation 9.044 |
| Acute Phase: ZS 10 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 4 hour Post 1st Dose Percent change | -11.58 percentage | Standard Deviation 7.645 |
| Acute Phase: ZS 10 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 1 hour Post 1st Dose Percent change | -12.70 percentage | Standard Deviation 8.091 |
| Acute Phase: ZS 10 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 2 hour Post 1st Dose Percent change | -3.43 percentage | Standard Deviation 6.779 |
| Acute Phase: ZS 10 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 1: 1 hour Post 1st Dose Percent change | -2.08 percentage | Standard Deviation 6.873 |
| Acute Phase: ZS 10 g TID | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Study Day 2: 0 hour Pre-dose Percent change | -9.85 percentage | Standard Deviation 6.693 |
Secondary
Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points.
Mean percent change from subacute baseline in serum potassium at all time points during subacute phase
Time frame: Through 18 days of subacute phase (12 days treatment, 6 days follow-up)
Population: ITT population. One subject (087-025) in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Phase: Placebo TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 Percent Change | 0.66 percentage | Standard Deviation 7.386 |
| Acute Phase: Placebo TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 Percent Change | 1.15 percentage | Standard Deviation 7.93 |
| Acute Phase: Placebo TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 Percent Change | 1.56 percentage | Standard Deviation 10.145 |
| Acute Phase: Placebo TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 Percent Change | 1.13 percentage | Standard Deviation 9.955 |
| Acute Phase: Placebo TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 Percent Change | -1.05 percentage | Standard Deviation 12.031 |
| Acute Phase: Placebo TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 Percent Change | 2.46 percentage | Standard Deviation 8.048 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 Percent Change | 2.79 percentage | Standard Deviation 8.465 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 Percent Change | 3.95 percentage | Standard Deviation 7.55 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 Percent Change | 2.56 percentage | Standard Deviation 9.098 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 Percent Change | 3.31 percentage | Standard Deviation 8.848 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 Percent Change | 1.58 percentage | Standard Deviation 8.271 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 Percent Change | 4.73 percentage | Standard Deviation 10.015 |
| Acute Phase: ZS 2.5 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 Percent Change | 4.74 percentage | Standard Deviation 8.819 |
| Acute Phase: ZS 2.5 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 Percent Change | 2.19 percentage | Standard Deviation 9.338 |
| Acute Phase: ZS 2.5 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 Percent Change | 1.79 percentage | Standard Deviation 9.198 |
| Acute Phase: ZS 2.5 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 Percent Change | 4.16 percentage | Standard Deviation 10.727 |
| Acute Phase: ZS 2.5 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 Percent Change | 4.83 percentage | Standard Deviation 10.881 |
| Acute Phase: ZS 2.5 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 Percent Change | 3.79 percentage | Standard Deviation 8.956 |
| Acute Phase: ZS 5 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 Percent Change | 2.90 percentage | Standard Deviation 7.769 |
| Acute Phase: ZS 5 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 Percent Change | 4.12 percentage | Standard Deviation 7.87 |
| Acute Phase: ZS 5 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 Percent Change | 4.35 percentage | Standard Deviation 11.587 |
| Acute Phase: ZS 5 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 Percent Change | 2.58 percentage | Standard Deviation 7.055 |
| Acute Phase: ZS 5 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 Percent Change | 1.30 percentage | Standard Deviation 7.766 |
| Acute Phase: ZS 5 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 Percent Change | 5.33 percentage | Standard Deviation 9.976 |
| Acute Phase: ZS 10 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 Percent Change | 2.96 percentage | Standard Deviation 8.913 |
| Acute Phase: ZS 10 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 Percent Change | 2.03 percentage | Standard Deviation 9.511 |
| Acute Phase: ZS 10 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 Percent Change | 4.15 percentage | Standard Deviation 9.464 |
| Acute Phase: ZS 10 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 Percent Change | 6.16 percentage | Standard Deviation 11.061 |
| Acute Phase: ZS 10 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 Percent Change | 5.67 percentage | Standard Deviation 12.4 |
| Acute Phase: ZS 10 g TID | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 Percent Change | 6.00 percentage | Standard Deviation 11.393 |
| Subacute Phase: ZS 5 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 Percent Change | 2.82 percentage | Standard Deviation 11.259 |
| Subacute Phase: ZS 5 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 Percent Change | 2.54 percentage | Standard Deviation 11.925 |
| Subacute Phase: ZS 5 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 Percent Change | 7.07 percentage | Standard Deviation 11.918 |
| Subacute Phase: ZS 5 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 Percent Change | 2.90 percentage | Standard Deviation 9.738 |
| Subacute Phase: ZS 5 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 Percent Change | 3.53 percentage | Standard Deviation 11.664 |
| Subacute Phase: ZS 5 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 Percent Change | 2.84 percentage | Standard Deviation 11.565 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 Percent Change | 8.73 percentage | Standard Deviation 9.982 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 Percent Change | 10.22 percentage | Standard Deviation 11.027 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 Percent Change | 6.58 percentage | Standard Deviation 8.908 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 Percent Change | 13.52 percentage | Standard Deviation 11.493 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 Percent Change | 3.15 percentage | Standard Deviation 8.368 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 Percent Change | 13.80 percentage | Standard Deviation 12.182 |
| Subacute Phase: ZS 10 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 Percent Change | 2.90 percentage | Standard Deviation 12.396 |
| Subacute Phase: ZS 10 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 Percent Change | 10.38 percentage | Standard Deviation 14.581 |
| Subacute Phase: ZS 10 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 Percent Change | -0.52 percentage | Standard Deviation 11.59 |
| Subacute Phase: ZS 10 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 Percent Change | 1.88 percentage | Standard Deviation 12.344 |
| Subacute Phase: ZS 10 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 Percent Change | 0.45 percentage | Standard Deviation 9.412 |
| Subacute Phase: ZS 10 g QD | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 Percent Change | 0.67 percentage | Standard Deviation 11.555 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 Percent Change | 1.26 percentage | Standard Deviation 7.859 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 Percent Change | 2.49 percentage | Standard Deviation 8.51 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 Percent Change | 1.94 percentage | Standard Deviation 10.241 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 Percent Change | 1.59 percentage | Standard Deviation 8.948 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 Percent Change | 1.18 percentage | Standard Deviation 8.583 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 Percent Change | 0.07 percentage | Standard Deviation 9.117 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 6 Percent Change | 3.05 percentage | Standard Deviation 9.397 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 12 Percent Change | 1.10 percentage | Standard Deviation 9.679 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 3 Percent Change | 1.12 percentage | Standard Deviation 10.533 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 18 Percent Change | 3.01 percentage | Standard Deviation 10.301 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 1 Percent Change | 0.99 percentage | Standard Deviation 7.696 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Subacute Day 2 Percent Change | 2.67 percentage | Standard Deviation 8.257 |
Secondary
Percentage of Subjects Who Achieve Normalization in S-K Levels After 48 Hours of Treatment
Time frame: Through 48 hours acute phase
Population: Subjects from ITT population who have completed Acute phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Phase: Placebo TID | Percentage of Subjects Who Achieve Normalization in S-K Levels After 48 Hours of Treatment | 47.8 percentage of participants |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Percentage of Subjects Who Achieve Normalization in S-K Levels After 48 Hours of Treatment | 51.3 percentage of participants |
| Acute Phase: ZS 2.5 g TID | Percentage of Subjects Who Achieve Normalization in S-K Levels After 48 Hours of Treatment | 67.9 percentage of participants |
| Acute Phase: ZS 5 g TID | Percentage of Subjects Who Achieve Normalization in S-K Levels After 48 Hours of Treatment | 77.6 percentage of participants |
| Acute Phase: ZS 10 g TID | Percentage of Subjects Who Achieve Normalization in S-K Levels After 48 Hours of Treatment | 86.4 percentage of participants |
Secondary
Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase
Percentage of subjects within each treatment group who retained normal S-K values (values between 3.5-5.0 mmol/L) at end of subacute phase
Time frame: Through 18 days of subacute phase (12 days treatment, 6 days follow-up)
Population: ITT population. One subject (087-025) in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Phase: Placebo TID | Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase | 73.2 percentage of participants |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase | 59.2 percentage of participants |
| Acute Phase: ZS 2.5 g TID | Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase | 65.2 percentage of participants |
| Acute Phase: ZS 5 g TID | Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase | 64.8 percentage of participants |
| Acute Phase: ZS 10 g TID | Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase | 54.4 percentage of participants |
| Subacute Phase: ZS 5 g QD | Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase | 57.8 percentage of participants |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase | 60.7 percentage of participants |
| Subacute Phase: ZS 10 g QD | Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase | 61.9 percentage of participants |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase | 67.4 percentage of participants |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase | 66 percentage of participants |
Secondary
Time Subjects Remain Normokalemic (Subacute Phase)
Time (number of days) subjects remain normokalemic (3.5 - 5.0 mmol/l) subacute phase
Time frame: Through 18 days (12 days treatment, 6 days follow-up) of subacute phase
Population: ITT population. One subject (087-025) in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Phase: Placebo TID | Time Subjects Remain Normokalemic (Subacute Phase) | 7.6 Days | Standard Deviation 4.71 |
| Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Time Subjects Remain Normokalemic (Subacute Phase) | 7.2 Days | Standard Deviation 5.08 |
| Acute Phase: ZS 2.5 g TID | Time Subjects Remain Normokalemic (Subacute Phase) | 6.2 Days | Standard Deviation 4.78 |
| Acute Phase: ZS 5 g TID | Time Subjects Remain Normokalemic (Subacute Phase) | 8.6 Days | Standard Deviation 4.55 |
| Acute Phase: ZS 10 g TID | Time Subjects Remain Normokalemic (Subacute Phase) | 6.0 Days | Standard Deviation 4.43 |
| Subacute Phase: ZS 5 g QD | Time Subjects Remain Normokalemic (Subacute Phase) | 9.0 Days | Standard Deviation 4.22 |
| Subacute Phase: Placebo Matched to ZS 10 g QD | Time Subjects Remain Normokalemic (Subacute Phase) | 8.2 Days | Standard Deviation 4.64 |
| Subacute Phase: ZS 10 g QD | Time Subjects Remain Normokalemic (Subacute Phase) | 10.2 Days | Standard Deviation 3.96 |
| Subacute Phase: ZS 1.25 (Acute Phase: Placebo) | Time Subjects Remain Normokalemic (Subacute Phase) | 8.5 Days | Standard Deviation 4.57 |
| Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo) | Time Subjects Remain Normokalemic (Subacute Phase) | 8.2 Days | Standard Deviation 4.72 |