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Trial record 37 of 119 for:    ZIRCONIUM

Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01737697
Recruitment Status : Completed
First Posted : November 29, 2012
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
ZS Pharma, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Hyperkalemia
Interventions Drug: Zirconium silicate (acute phase)
Drug: Zirconium silicate (subacute phase)
Drug: Placebo (acute phase)
Drug: Placebo ( subacute phase)
Enrollment 754
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.
Arm/Group Title Acute Phase: Placebo 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 Subacute Phase: Placebo Matched to ZS 1.25g QD Subacute Phase: ZS 1.25 g QD Subacute Phase: Placebo Matched to ZS 2.5 g QD Subacute Phase: ZS 2.5 g QD Subacute Phase: Placebo Matched to ZS 5 g QD Subacute Phase: ZS 5 g QD Subacute Phase: Placebo Matched to ZS 10 g QD Subacute Phase: ZS 10 g QD Subacute Phase: ZS 1.25 (Acute Phase: Placebo) Subacute Phase: ZS 2.5 g (Acute Phase: Placebo)
Hide Arm/Group Description Participants administered placebo as suspension orally three times a day (TID) for first 48 hours. Participants administered ZS 1.25 g TID as suspension orally for first 48 hours. Participants administered ZS 2.5 g TID as suspension orally for first 48 hours. Participants administered ZS 5 g TID as suspension orally for first 48 hours. Participants administered ZS 10 g TID as suspension orally for first 48 hours. Participants who received ZS 1.25 g TID in the acute phase and administered placebo as suspension once daily (QD) for 12 days. Participants who received ZS 1.25g TID in the acute phase and administered ZS 1.25 g QD for 12 days. Participants who received ZS 2.5 g TID in the acute phase and administered placebo as suspension QD for 12 days. Participants who received ZS 2.5 g TID in the acute phase and administered ZS 2.5 g as suspension QD for 12 days. Participants who received ZS 5 g TID in the acute phase and administered placebo as suspension QD for 12 days. Participants who received ZS 5 g TID in the acute phase and administered ZS 5 g as suspension QD for 12 days. Participants who received ZS 10 g TID in the acute phase and administered placebo as suspension QD for 12 days. Participants who received ZS 10 g TID in the acute phase and administered ZS 10 g QD as suspension for 12 days. Participants who received placebo in the acute phase and administered ZS 1.25 g as suspension QD for 12 days. Participants who received placebo in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
Period Title: Acute Phase-Initial 48 Hours
Started 158 154 141 158 143 0 0 0 0 0 0 0 0 0 0
Completed 157 150 137 152 140 0 0 0 0 0 0 0 0 0 0
Not Completed 1 4 4 6 3 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             1             0             1             1             0             0             0             0             0             0             0             0             0             0
hypo-or hyperkalemia             1             1             3             0             0             0             0             0             0             0             0             0             0             0             0
Family emergency             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0
Sponsor's decision             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             1             1             4             1             0             0             0             0             0             0             0             0             0             0
Period Title: Subacute Phase
Started 0 0 0 0 0 41 49 46 54 68 65 61 63 46 50
Completed 0 0 0 0 0 38 48 43 52 66 59 58 61 44 49
Not Completed 0 0 0 0 0 3 1 3 2 2 6 3 2 2 1
Reason Not Completed
Adverse Event             0             0             0             0             0             1             1             1             1             1             4             1             1             0             0
Withdrawal by Subject             0             0             0             0             0             1             0             2             0             1             0             1             1             1             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1
Hypo-or hyperkalemia             0             0             0             0             0             0             0             0             0             0             0             1             0             1             0
Protocol Violation             0             0             0             0             0             1             0             0             0             0             1             0             0             0             0
Physician Decision             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0
Death             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0
Arm/Group Title Acute Phase: Placebo TID 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
Hide Arm/Group Description Participants administered placebo three times daily (TID) orally as suspension for first 48 hours. Participants administered ZS 1.25 g TID as suspension orally for first 48 hours. Participants administered ZS 2.5 g TID as suspension orally for first 48 hours. Participants administered ZS 5 g TID as suspension orally for first 48 hours. Participants administered ZS 10 g TID as suspension orally for first 48 hours. Total of all reporting groups
Overall Number of Baseline Participants 158 154 141 157 143 753
Hide Baseline Analysis Population Description
One subject in ZS 5g group was randomized but was not treated and is excluded from baseline characatertics.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Acute Phase Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
65.6  (12.24) 65.4  (13.07) 65.9  (11.73) 65.2  (11.91) 66.2  (12.16) 65.6  (12.24)
Sex/Gender, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
Female
60
  38.0%
71
  46.1%
50
  35.5%
61
  38.9%
63
  44.1%
305
  40.5%
Male
98
  62.0%
83
  53.9%
91
  64.5%
96
  61.1%
80
  55.9%
448
  59.5%
[1]
Measure Description: Sex/Gender, Customized. Gender by Acute Phase
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
136 131 125 132 120 644
Black or African American Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
17 20 11 20 19 87
Asian Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
2 0 5 3 2 12
American Indian or Alaska Native Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
2 0 0 1 1 4
Native Hawaiian or other Pacific Islander Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
1 3 0 0 1 5
Other Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
0 0 1 1 0 2
Multiple Races Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
0 0 1 0 0 1
[1]
Measure Description: Race/Ethnicity, Customized. Categories are not mutually exclusive
Acute S-K baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
≤ 5.3 mmol/L
95
  60.1%
76
  49.4%
72
  51.1%
90
  57.3%
94
  65.7%
427
  56.7%
5.4-5.5 mmol/L
22
  13.9%
38
  24.7%
29
  20.6%
36
  22.9%
27
  18.9%
152
  20.2%
> 5.5 mmol/L
41
  25.9%
40
  26.0%
40
  28.4%
31
  19.7%
22
  15.4%
174
  23.1%
Etiology of elevated S-K   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Chronic kidney disease Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
96
  60.8%
102
  66.2%
89
  63.1%
93
  59.2%
83
  58.0%
463
  61.5%
Congestive heart failure Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
66
  41.8%
57
  37.0%
54
  38.3%
64
  40.8%
59
  41.3%
300
  39.8%
Diabetes mellitus Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
96
  60.8%
94
  61.0%
84
  59.6%
96
  61.1%
81
  56.6%
451
  59.9%
RAAS inhibitor medication Number Analyzed 158 participants 154 participants 141 participants 157 participants 143 participants 753 participants
101
  63.9%
109
  70.8%
97
  68.8%
99
  63.1%
96
  67.1%
502
  66.7%
[1]
Measure Description: Etiology of elevated S-K. Categories are not mutually exclusive
Baseline eGFR   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
<15 ml/min Number Analyzed 158 participants 151 participants 138 participants 154 participants 143 participants 744 participants
15
   9.5%
8
   5.3%
15
  10.9%
8
   5.2%
10
   7.0%
56
   7.5%
15-29+ ml/min Number Analyzed 158 participants 151 participants 138 participants 154 participants 143 participants 744 participants
44
  27.8%
42
  27.8%
38
  27.5%
43
  27.9%
42
  29.4%
209
  28.1%
30-59+ mL/min Number Analyzed 158 participants 151 participants 138 participants 154 participants 143 participants 744 participants
61
  38.6%
73
  48.3%
48
  34.8%
64
  41.6%
50
  35.0%
296
  39.8%
≥60 mL/min Number Analyzed 158 participants 151 participants 138 participants 154 participants 143 participants 744 participants
38
  24.1%
28
  18.5%
37
  26.8%
39
  25.3%
41
  28.7%
183
  24.6%
[1]
Measure Description: Acute phase baseline - estimated Glomerular filtration rate (eGFR)
[2]
Measure Analysis Population Description: Subjects with non-missing acute phase baseline eGFR
1.Primary Outcome
Title Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment.
Hide Description [Not Specified]
Time Frame Through 48 hours acute phase
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Acute Phase: Placebo TID 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 g TID
Hide Arm/Group Description:
Participants administered placebo three times daily (TID) orally as suspension for first 48 hours.
Participants administered ZS 1.25 g TID as suspension orally for first 48 hours.
Participants administered ZS 2.5 g TID as suspension orally for first 48 hours.
Participants administered ZS 5 g TID as suspension orally for first 48 hours.
Participants administered ZS 10 g TID as suspension orally for first 48 hours.
Overall Number of Participants Analyzed 158 154 141 157 143
Mean (Standard Error)
Unit of Measure: log(mmol/L)/hour
Through 24 Hours -0.00128  (0.000243) -0.00187  (0.000250) -0.00205  (0.000263) -0.00280  (0.000250) -0.00382  (0.000258)
Through 48 Hours -0.00097  (0.000137) -0.00110  (0.000141) -0.00163  (0.000148) -0.00223  (0.000141) -0.00321  (0.000145)
2.Primary Outcome
Title Exponential Rate of Change in S-K Levels in the Subacute Phase.
Hide Description [Not Specified]
Time Frame Through 12 days subacute phase (Day 3 through Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Subacute Phase: Placebo Matched to ZS 1.25 g QD Subacute Phase: ZS 1.25 g QD Subacute Phase: Placebo Matched to ZS 2.5 g QD Subacute Phase: ZS 2.5 g QD Subacute Phase: Placebo Matched to ZS 5 g QD Subacute Phase: ZS 5 g QD Subacute Phase: Placebo Matched to ZS 10 g QD Subacute Phase: ZS 10 g QD Subacute Phase: ZS 1.25 (Acute Phase: Placebo) Subacute Phase: ZS 2.5 g ( Acute Phase: Placebo)
Hide Arm/Group Description:
Participants who received ZS 1.25 g TID in the acute phase and received placebo matched to ZS 1.25 g QD for 12 days.
Participants who received ZS 1.25g TID in the acute phase and administered ZS 1.25 g QD for 12 days.
Participants who received ZS 2.5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 2.5 g TID in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
Participants who received ZS 5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 5 g TID in the acute phase and administered ZS 5 g as suspension QD for 12 days.
Participants who received ZS 10 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 10 g TID in the acute phase and administered ZS 10 g QD as suspension for 12 days.
Participants who received placebo in the acute phase and administered ZS 1.25 g as suspension QD for 12 days.
Participants who received placebo in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
Overall Number of Participants Analyzed 41 49 46 54 68 64 61 63 46 50
Mean (Standard Error)
Unit of Measure: log(mmol/L)/hour
Through Day 8 0.00054  (0.004803) 0.00874  (0.004308) 0.01104  (0.004123) 0.00734  (0.003642) 0.01441  (0.003776) 0.00581  (0.003918) 0.02469  (0.003939) -0.00053  (0.003877) 0.00643  (0.004171) 0.00390  (0.004023)
Through Day 15 0.00085  (0.001089) 0.00198  (0.000959) 0.00206  (0.001189) 0.00237  (0.001049) 0.00457  (0.001007) 0.00089  (0.001049) 0.00979  (0.001115) 0.00136  (0.001097) -0.00098  (0.001054) 0.00023  (0.001004)
3.Secondary Outcome
Title Percentage of Subjects Who Achieve Normalization in S-K Levels After 48 Hours of Treatment
Hide Description [Not Specified]
Time Frame Through 48 hours acute phase
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects from ITT population who have completed Acute phase
Arm/Group Title Acute Phase: Placebo TID 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 g TID
Hide Arm/Group Description:
Participants administered placebo three times daily (TID) orally as suspension for first 48 hours.
Participants administered ZS 1.25 g TID as suspension orally for first 48 hours.
Participants administered ZS 2.5 g TID as suspension orally for first 48 hours.
Participants administered ZS 5 g TID as suspension orally for first 48 hours.
Participants administered ZS 10 g TID as suspension orally for first 48 hours.
Overall Number of Participants Analyzed 157 150 137 152 140
Measure Type: Number
Unit of Measure: percentage of participants
47.8 51.3 67.9 77.6 86.4
4.Secondary Outcome
Title Mean Change From Baseline in S-K at All Time Points Acute Phase
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Acute Phase: Placebo TID 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 g TID
Hide Arm/Group Description:
Participants administered placebo three times daily (TID) orally as suspension for first 48 hours.
Participants administered ZS 1.25 g TID as suspension orally for first 48 hours.
Participants administered ZS 2.5 g TID as suspension orally for first 48 hours.
Participants administered ZS 5 g TID as suspension orally for first 48 hours.
Participants administered ZS 10 g TID as suspension orally for first 48 hours.
Overall Number of Participants Analyzed 158 154 141 157 143
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline, mean 5.30  (0.365) 5.37  (0.369) 5.35  (0.400) 5.31  (0.337) 5.26  (0.337)
Study Day 1: 1 hour Post 1st Dose 0.01  (0.404) -0.01  (0.360) -0.08  (0.394) -0.06  (0.413) -0.11  (0.361)
Study Day 1: 2 hour Post 1st Dose 0.00  (0.423) -0.04  (0.366) -0.06  (0.499) -0.09  (0.355) -0.18  (0.360)
Study Day 1: 4 hour Post 1st Dose -0.22  (0.429) -0.28  (0.425) -0.34  (0.409) -0.31  (0.389) -0.37  (0.445)
Study Day 2: 0 hour Pre-dose -0.18  (0.363) -0.28  (0.393) -0.32  (0.390) -0.40  (0.375) -0.52  (0.364)
Study Day 2: 1 hour Post 1st Dose -0.24  (0.484) -0.27  (0.415) -0.38  (0.479) -0.46  (0.440) -0.68  (0.437)
Study Day 2: 4 hour Post 1st Dose -0.22  (0.440) -0.32  (0.449) -0.40  (0.462) -0.47  (0.465) -0.62  (0.420)
Study Day 3: 0 hour Pre-dose -0.25  (0.413) -0.30  (0.404) -0.46  (0.398) -0.54  (0.459) -0.73  (0.496)
5.Secondary Outcome
Title Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Acute Phase: Placebo TID 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 g TID
Hide Arm/Group Description:
Participants administered placebo three times daily (TID) orally as suspension for first 48 hours.
Participants administered ZS 1.25 g TID as suspension orally for first 48 hours.
Participants administered ZS 2.5 g TID as suspension orally for first 48 hours.
Participants administered ZS 5 g TID as suspension orally for first 48 hours.
Participants administered ZS 10 g TID as suspension orally for first 48 hours.
Overall Number of Participants Analyzed 158 154 141 157 143
Mean (Standard Deviation)
Unit of Measure: percentage
Study Day 1: 1 hour Post 1st Dose Percent change 0.09  (7.606) -0.23  (6.732) -1.37  (7.273) -1.13  (7.791) -2.08  (6.873)
Study Day 1: 2 hour Post 1st Dose Percent change 0.03  (7.911) -0.81  (6.813) -0.99  (9.384) -1.71  (6.725) -3.43  (6.779)
Study Day 1: 4 hour Post 1st Dose Percent change -4.05  (8.021) -5.20  (7.842) -6.34  (7.460) -5.74  (7.283) -6.91  (8.249)
Study Day 2: 0 hour Pre-dose Percent change -3.40  (6.819) -5.14  (7.190) -6.02  (7.099) -7.31  (6.942) -9.85  (6.693)
Study Day 2: 1 hour Post 1st Dose Percent change -4.42  (8.904) -4.99  (7.717) -6.95  (8.910) -8.62  (8.082) -12.70  (8.091)
Study Day 2: 4 hour Post 1st Dose Percent change -4.08  (8.253) -5.82  (8.187) -7.27  (8.405) -8.63  (8.541) -11.58  (7.645)
Study Day 3: 0 hour Pre-dose Percent change -4.62  (7.751) -5.44  (7.476) -8.48  (7.291) -10.04  (8.33) -13.76  (9.044)
6.Secondary Outcome
Title Time Subjects Remain Normokalemic (Subacute Phase)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Subacute Phase: Placebo Matched to ZS 1.25 g QD Subacute Phase: ZS 1.25 g QD Subacute Phase: Placebo Matched to ZS 2.5 g QD Subacute Phase: ZS 2.5 g QD Subacute Phase: Placebo Matched to ZS 5 g QD Subacute Phase: ZS 5 g QD Subacute Phase: Placebo Matched to ZS 10 g QD Subacute Phase: ZS 10 g QD Subacute Phase: ZS 1.25 (Acute Phase: Placebo) Subacute Phase: ZS 2.5 g (Acute Phase: Placebo)
Hide Arm/Group Description:
Participants who received ZS 1.25 g TID in the acute phase and received placebo matched to ZS 1.25 g QD for 12 days.
Participants who received ZS 1.25g TID in the acute phase and administered ZS 1.25 g QD for 12 days.
Participants who received ZS 2.5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 2.5 g TID in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
Participants who received ZS 5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 5 g TID in the acute phase and administered ZS 5 g as suspension QD for 12 days.
Participants who received ZS 10 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 10 g TID in the acute phase and administered ZS 10 g QD as suspension for 12 days.
Participants who received placebo in the acute phase and administered ZS 1.25 g as suspension QD for 12 days.
Participants who received placebo in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
Overall Number of Participants Analyzed 41 49 46 54 68 64 61 63 46 50
Mean (Standard Deviation)
Unit of Measure: Days
7.6  (4.71) 7.2  (5.08) 6.2  (4.78) 8.6  (4.55) 6.0  (4.43) 9.0  (4.22) 8.2  (4.64) 10.2  (3.96) 8.5  (4.57) 8.2  (4.72)
7.Secondary Outcome
Title Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Subacute Phase: Placebo Matched to ZS 1.25 g QD Subacute Phase: ZS 1.25 g QD Subacute Phase: Placebo Matched to ZS 2.5 g QD Subacute Phase: ZS 2.5 g QD Subacute Phase: Placebo Matched to ZS 5 g QD Subacute Phase: ZS 5 g QD Subacute Phase: Placebo Matched to ZS 10 g QD Subacute Phase: ZS 10 g QD Subacute Phase: ZS 1.25 (Acute Phase: Placebo) Subacute Phase: ZS 2.5 g (Acute Phase: Placebo)
Hide Arm/Group Description:
Participants who received ZS 1.25 g TID in the acute phase and received placebo matched to ZS 1.25 g QD for 12 days.
Participants who received ZS 1.25g TID in the acute phase and administered ZS 1.25 g QD for 12 days.
Participants who received ZS 2.5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 2.5 g TID in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
Participants who received ZS 5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 5 g TID in the acute phase and administered ZS 5 g as suspension QD for 12 days.
Participants who received ZS 10 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 10 g TID in the acute phase and administered ZS 10 g QD as suspension for 12 days.
Participants who received placebo in the acute phase and administered ZS 1.25 g as suspension QD for 12 days.
Participants who received placebo in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
Overall Number of Participants Analyzed 41 49 46 54 68 64 61 63 46 50
Measure Type: Number
Unit of Measure: percentage of participants
73.2 59.2 65.2 64.8 54.4 57.8 60.7 61.9 67.4 66
8.Secondary Outcome
Title Mean Change From Subacute Baseline in Serum Potassium at All Time Points.
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Subacute Phase: Placebo Matched to ZS 1.25 g QD Subacute Phase: ZS 1.25 g QD Subacute Phase: Placebo Matched to ZS 2.5 g QD Subacute Phase: ZS 2.5 g QD Subacute Phase: Placebo Matched to ZS 5 g QD Subacute Phase: ZS 5 g QD Subacute Phase: Placebo Matched to ZS 10 g QD Subacute Phase: ZS 10 g QD Subacute Phase: ZS 1.25 (Acute Phase: Placebo) Subacute Phase: ZS 2.5 g (Acute Phase: Placebo)
Hide Arm/Group Description:
Participants who received ZS 1.25 g TID in the acute phase and received placebo matched to ZS 1.25 g QD for 12 days.
Participants who received ZS 1.25g TID in the acute phase and administered ZS 1.25 g QD for 12 days.
Participants who received ZS 2.5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 2.5 g TID in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
Participants who received ZS 5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 5 g TID in the acute phase and administered ZS 5 g as suspension QD for 12 days.
Participants who received ZS 10 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 10 g TID in the acute phase and administered ZS 10 g QD as suspension for 12 days.
Participants who received placebo in the acute phase and administered ZS 1.25 g as suspension QD for 12 days.
Participants who received placebo in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
Overall Number of Participants Analyzed 41 49 46 54 68 64 61 63 46 50
Mean (Standard Deviation)
Unit of Measure: mmol/L
Acute Baseline, mean 5.22  (0.263) 5.29  (0.343) 5.25  (0.268) 5.23  (0.354) 5.31  (0.302) 5.24  (0.325) 5.24  (0.290) 5.27  (0.369) 5.15  (0.293) 5.19  (0.325)
Subacute Baseline, mean 4.81  (0.324) 4.80  (0.391) 4.77  (0.349) 4.66  (0.336) 4.76  (0.440) 4.63  (0.357) 4.42  (0.353) 4.52  (0.448) 4.81  (0.348) 4.80  (0.379)
Subacute Day 1 0.02  (0.362) 0.15  (0.416) 0.21  (0.416) 0.11  (0.329) 0.07  (0.493) 0.12  (0.446) 0.13  (0.363) 0.00  (0.452) 0.05  (0.373) 0.04  (0.362)
Subacute Day 2 -0.06  (0.575) 0.13  (0.405) 0.07  (0.451) 0.05  (0.360) 0.12  (0.477) 0.10  (0.519) 0.28  (0.387) 0.00  (0.531) 0.07  (0.437) 0.12  (0.389)
Subacute Day 3 0.04  (0.387) 0.11  (0.432) 0.17  (0.431) 0.18  (0.350) 0.17  (0.503) 0.11  (0.499) 0.37  (0.426) -0.06  (0.557) 0.11  (0.400) 0.03  (0.501)
Subacute Day 6 0.11  (0.385) 0.07  (0.411) 0.22  (0.532) 0.12  (0.356) 0.27  (0.560) 0.11  (0.510) 0.43  (0.467) 0.10  (0.573) 0.04  (0.409) 0.13  (0.457)
Subacute Day 12 0.04  (0.477) 0.18  (0.368) 0.18  (0.520) 0.23  (0.451) 0.24  (0.584) 0.14  (0.532) 0.58  (0.485) 0.06  (0.564) -0.01  (0.438) 0.04  (0.451)
Subacute Day 18 0.06  (0.474) 0.22  (0.459) 0.09  (0.442) 0.18  (0.522) 0.26  (0.555) 0.30  (0.539) 0.59  (0.504) 0.44  (0.652) 0.09  (0.477) 0.14  (0.492)
9.Secondary Outcome
Title Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points.
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Subacute Phase: Placebo Matched to ZS 1.25 g QD Subacute Phase: ZS 1.25 g QD Subacute Phase: Placebo Matched to ZS 2.5 g QD Subacute Phase: ZS 2.5 g QD Subacute Phase: Placebo Matched to ZS 5 g QD Subacute Phase: ZS 5 g QD Subacute Phase: Placebo Matched to ZS 10 g QD Subacute Phase: ZS 10 g QD Subacute Phase: ZS 1.25 (Acute Phase: Placebo) Subacute Phase: ZS 2.5 g (Acute Phase: Placebo)
Hide Arm/Group Description:
Participants who received ZS 1.25 g TID in the acute phase and received placebo matched to ZS 1.25 g QD for 12 days.
Participants who received ZS 1.25g TID in the acute phase and administered ZS 1.25 g QD for 12 days.
Participants who received ZS 2.5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 2.5 g TID in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
Participants who received ZS 5 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 5 g TID in the acute phase and administered ZS 5 g as suspension QD for 12 days.
Participants who received ZS 10 g TID in the acute phase and administered placebo as suspension QD for 12 days.
Participants who received ZS 10 g TID in the acute phase and administered ZS 10 g QD as suspension for 12 days.
Participants who received placebo in the acute phase and administered ZS 1.25 g as suspension QD for 12 days.
Participants who received placebo in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
Overall Number of Participants Analyzed 41 49 46 54 68 64 61 63 46 50
Mean (Standard Deviation)
Unit of Measure: percentage
Subacute Day 1 Percent Change 0.66  (7.386) 3.31  (8.848) 4.74  (8.819) 2.58  (7.055) 2.03  (9.511) 2.90  (9.738) 3.15  (8.368) 0.45  (9.412) 1.26  (7.859) 0.99  (7.696)
Subacute Day 2 Percent Change -1.05  (12.031) 2.79  (8.465) 1.79  (9.198) 1.30  (7.766) 2.96  (8.913) 2.54  (11.925) 6.58  (8.908) 0.67  (11.555) 1.59  (8.948) 2.67  (8.257)
Subacute Day 3 Percent Change 1.15  (7.930) 2.56  (9.098) 3.79  (8.956) 4.12  (7.870) 4.15  (9.464) 2.82  (11.259) 8.73  (9.982) -0.52  (11.590) 2.49  (8.510) 1.12  (10.533)
Subacute Day 6 Percent Change 2.46  (8.048) 1.58  (8.271) 4.83  (10.881) 2.90  (7.769) 6.16  (11.061) 2.84  (11.565) 10.22  (11.027) 2.90  (12.396) 1.18  (8.583) 3.05  (9.397)
Subacute Day 12 Percent Change 1.13  (9.955) 3.95  (7.550) 4.16  (10.727) 5.33  (9.976) 5.67  (12.400) 3.53  (11.664) 13.52  (11.493) 1.88  (12.344) 0.07  (9.117) 1.10  (9.679)
Subacute Day 18 Percent Change 1.56  (10.145) 4.73  (10.015) 2.19  (9.338) 4.35  (11.587) 6.00  (11.393) 7.07  (11.918) 13.80  (12.182) 10.38  (14.581) 1.94  (10.241) 3.01  (10.301)
Time Frame Seven days after the last dose of study medication. 21 days overall
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acute Phase: Placebo TID 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 Subacute Phase: Placebo Matched to ZS 1.25g QD Subacute Phase: ZS 1.25 g QD Subacute Phase: Placebo Matched to ZS 2.5 g QD Subacute Phase: ZS 2.5 g QD Subacute Phase: Placebo Matched to ZS 5 g QD Subacute Phase: ZS 5 g QD Subacute Phase: Placebo Matched to ZS 10 g QD Subacute Phase: ZS 10 g QD Subacute Phase: ZS 1.25 g QD (Acute Phase: Placebo) Subacute Phase: ZS 2.5 g QD (Acute Phase; Placebo)
Hide Arm/Group Description Participants administered placebo three times daily (TID) orally as suspension for first 48 hours. Participants administered ZS 1.25 g TID as suspension orally for first 48 hours. Participants administered ZS 2.5 g TID as suspension orally for first 48 hours. Participants administered ZS 5 g TID as suspension orally for first 48 hours. Participants administered ZS 10 g TID as suspension orally for first 48 hours. Participants who received ZS 1.25 g TID in the acute phase and administered placebo as suspension once daily (QD) for 12 days. Participants who received ZS 1.25g TID in the acute phase and administered ZS 1.25 g QD for 12 days. Participants who received ZS 2.5 g TID in the acute phase and administered placebo as suspension QD for 12 days. Participants who received ZS 2.5 g TID in the acute phase and administered ZS 2.5 g as suspension QD for 12 days. Participants who received ZS 5 g TID in the acute phase and administered placebo as suspension QD for 12 days. Participants who received ZS 5 g TID in the acute phase and administered ZS 5 g as suspension QD for 12 days. Participants who received ZS 10 g TID in the acute phase and administered placebo as suspension QD for 12 days. Participants who received ZS 10 g TID in the acute phase and administered ZS 10 g QD as suspension for 12 days. Participants who received placebo in the acute phase and administered ZS 1.25 g as suspension QD for 12 days. Participants who received placebo in the acute phase and administered ZS 2.5 g as suspension QD for 12 days.
All-Cause Mortality
Acute Phase: Placebo TID 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 Subacute Phase: Placebo Matched to ZS 1.25g QD Subacute Phase: ZS 1.25 g QD Subacute Phase: Placebo Matched to ZS 2.5 g QD Subacute Phase: ZS 2.5 g QD Subacute Phase: Placebo Matched to ZS 5 g QD Subacute Phase: ZS 5 g QD Subacute Phase: Placebo Matched to ZS 10 g QD Subacute Phase: ZS 10 g QD Subacute Phase: ZS 1.25 g QD (Acute Phase: Placebo) Subacute Phase: ZS 2.5 g QD (Acute Phase; Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Acute Phase: Placebo TID 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 Subacute Phase: Placebo Matched to ZS 1.25g QD Subacute Phase: ZS 1.25 g QD Subacute Phase: Placebo Matched to ZS 2.5 g QD Subacute Phase: ZS 2.5 g QD Subacute Phase: Placebo Matched to ZS 5 g QD Subacute Phase: ZS 5 g QD Subacute Phase: Placebo Matched to ZS 10 g QD Subacute Phase: ZS 10 g QD Subacute Phase: ZS 1.25 g QD (Acute Phase: Placebo) Subacute Phase: ZS 2.5 g QD (Acute Phase; Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/158 (0.63%)   0/154 (0.00%)   0/141 (0.00%)   0/157 (0.00%)   0/143 (0.00%)   1/41 (2.44%)   2/49 (4.08%)   1/46 (2.17%)   2/54 (3.70%)   2/68 (2.94%)   3/65 (4.62%)   1/61 (1.64%)   1/63 (1.59%)   1/46 (2.17%)   1/50 (2.00%) 
Cardiac disorders                               
Diastolic dysfunction  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Cardiac failure congestive  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
General disorders                               
Chest pain  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  1/49 (2.04%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Malaise  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  1/41 (2.44%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Infections and infestations                               
Gastroenteritis  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/61 (1.64%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Nocardiosis  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Pneumonia  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  1/46 (2.17%)  1/54 (1.85%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Urinary tract infection  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  1/54 (1.85%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Investigations                               
Blood potassium increased  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  1/49 (2.04%)  0/46 (0.00%)  0/54 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Metabolism and nutrition disorders                               
Gout  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  1/63 (1.59%)  0/46 (0.00%)  0/50 (0.00%) 
Nervous system disorders                               
Loss of consciousness  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Renal and urinary disorders                               
Renal failure  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Renal failure acute  1  1/158 (0.63%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Urinary retention  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  1/46 (2.17%)  0/50 (0.00%) 
Respiratory, thoracic and mediastinal disorders                               
Dyspnoea  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  1/49 (2.04%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  1/50 (2.00%) 
Pulmonary oedema  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Respiratory arrest  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Surgical and medical procedures                               
Hospitalization  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1E
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Acute Phase: Placebo TID 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 Subacute Phase: Placebo Matched to ZS 1.25g QD Subacute Phase: ZS 1.25 g QD Subacute Phase: Placebo Matched to ZS 2.5 g QD Subacute Phase: ZS 2.5 g QD Subacute Phase: Placebo Matched to ZS 5 g QD Subacute Phase: ZS 5 g QD Subacute Phase: Placebo Matched to ZS 10 g QD Subacute Phase: ZS 10 g QD Subacute Phase: ZS 1.25 g QD (Acute Phase: Placebo) Subacute Phase: ZS 2.5 g QD (Acute Phase; Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/158 (5.70%)   18/154 (11.69%)   6/141 (4.26%)   6/157 (3.82%)   10/143 (6.99%)   14/41 (34.15%)   10/49 (20.41%)   7/46 (15.22%)   13/54 (24.07%)   12/68 (17.65%)   14/65 (21.54%)   6/61 (9.84%)   16/63 (25.40%)   8/46 (17.39%)   6/50 (12.00%) 
Cardiac disorders                               
Atrial fibrilliation  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/61 (0.00%)  1/63 (1.59%)  0/46 (0.00%)  0/50 (0.00%) 
Gastrointestinal disorders                               
Constipation  1  1/158 (0.63%)  1/154 (0.65%)  1/141 (0.71%)  1/157 (0.64%)  3/143 (2.10%)  1/41 (2.44%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  2/63 (3.17%)  2/46 (4.35%)  0/50 (0.00%) 
Diarrhoea  1  4/158 (2.53%)  5/154 (3.25%)  2/141 (1.42%)  3/157 (1.91%)  1/143 (0.70%)  0/41 (0.00%)  0/49 (0.00%)  2/46 (4.35%)  2/54 (3.70%)  3/68 (4.41%)  2/65 (3.08%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  2/50 (4.00%) 
Dyspepsia  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  2/65 (3.08%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Nausea  1  1/158 (0.63%)  2/154 (1.30%)  0/141 (0.00%)  1/157 (0.64%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  1/46 (2.17%)  2/54 (3.70%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  1/63 (1.59%)  3/46 (6.52%)  0/50 (0.00%) 
Vomiting  1  2/158 (1.27%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  1/143 (0.70%)  0/41 (0.00%)  0/49 (0.00%)  1/46 (2.17%)  2/54 (3.70%)  0/68 (0.00%)  3/65 (4.62%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
General disorders                               
Malaise  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  1/41 (2.44%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  1/63 (1.59%)  0/46 (0.00%)  0/50 (0.00%) 
Oedema peripheral  1  0/158 (0.00%)  1/154 (0.65%)  0/141 (0.00%)  0/157 (0.00%)  2/143 (1.40%)  1/41 (2.44%)  1/49 (2.04%)  0/46 (0.00%)  0/54 (0.00%)  2/68 (2.94%)  0/65 (0.00%)  0/61 (0.00%)  2/63 (3.17%)  0/46 (0.00%)  2/50 (4.00%) 
Infections and infestations                               
Pneumonia  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  1/46 (2.17%)  1/54 (1.85%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Streptococcal urinary tract infection  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  2/50 (4.00%) 
Upper respiratory tract infection  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  1/41 (2.44%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/61 (0.00%)  1/63 (1.59%)  0/46 (0.00%)  0/50 (0.00%) 
Urinary tract infection  1  0/158 (0.00%)  5/154 (3.25%)  0/141 (0.00%)  1/157 (0.64%)  0/143 (0.00%)  4/41 (9.76%)  4/49 (8.16%)  1/46 (2.17%)  3/54 (5.56%)  0/68 (0.00%)  5/65 (7.69%)  0/61 (0.00%)  4/63 (6.35%)  3/46 (6.52%)  0/50 (0.00%) 
Urinary tract infection, bacterial  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  1/68 (1.47%)  1/65 (1.54%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Injury, poisoning and procedural complications                               
Laceration  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  1/41 (2.44%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/61 (1.64%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Investigations                               
Blood glucose decreased  1  0/158 (0.00%)  1/154 (0.65%)  1/141 (0.71%)  0/157 (0.00%)  1/143 (0.70%)  1/41 (2.44%)  0/49 (0.00%)  0/46 (0.00%)  1/54 (1.85%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Blood potassium increased  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  1/49 (2.04%)  0/46 (0.00%)  0/54 (0.00%)  1/68 (1.47%)  1/65 (1.54%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Transaminases increased  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  1/61 (1.64%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Musculoskeletal and connective tissue disorders                               
Muscle spasms  1  0/158 (0.00%)  0/154 (0.00%)  1/141 (0.71%)  0/157 (0.00%)  1/143 (0.70%)  0/41 (0.00%)  1/49 (2.04%)  0/46 (0.00%)  1/54 (1.85%)  1/68 (1.47%)  0/65 (0.00%)  1/61 (1.64%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Renal and urinary disorders                               
Haematuria  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  1/41 (2.44%)  1/49 (2.04%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Renal failure acute  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  1/54 (1.85%)  0/68 (0.00%)  0/65 (0.00%)  1/61 (1.64%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Renal impairment  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  1/41 (2.44%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  1/63 (1.59%)  0/46 (0.00%)  0/50 (0.00%) 
Respiratory, thoracic and mediastinal disorders                               
Chronic obstructive pulmonary disease  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  2/41 (4.88%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/63 (0.00%)  0/46 (0.00%)  0/50 (0.00%) 
Cough  1  1/158 (0.63%)  1/154 (0.65%)  1/141 (0.71%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  1/49 (2.04%)  1/46 (2.17%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  1/63 (1.59%)  0/46 (0.00%)  0/50 (0.00%) 
Dyspnoea  1  0/158 (0.00%)  0/154 (0.00%)  0/141 (0.00%)  0/157 (0.00%)  0/143 (0.00%)  0/41 (0.00%)  1/49 (2.04%)  0/46 (0.00%)  0/54 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  1/63 (1.59%)  0/46 (0.00%)  0/50 (0.00%) 
Vascular disorders                               
Hypertension  1  0/158 (0.00%)  2/154 (1.30%)  0/141 (0.00%)  0/157 (0.00%)  1/143 (0.70%)  0/41 (0.00%)  0/49 (0.00%)  0/46 (0.00%)  0/54 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  2/61 (3.28%)  1/63 (1.59%)  0/46 (0.00%)  0/50 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1E
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
ZS Pharma has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: AstraZeneca Clinical Study Information Center
Organization: ZS Pharma, Inc.
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: ZS Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01737697     History of Changes
Other Study ID Numbers: ZS-003
First Submitted: November 19, 2012
First Posted: November 29, 2012
Results First Submitted: October 2, 2017
Results First Posted: October 12, 2018
Last Update Posted: October 12, 2018