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Trial record 53 of 119 for:    ZIRCONIUM

ZS Ph2/3 Dose-response Study in Japan

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: NCT03127644
Recruitment Status : Completed
First Posted : April 25, 2017
Results First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hyperkalemia
Interventions Drug: Sodium Zirconium Cyclosilicate (ZS) 5g
Drug: Sodium Zirconium Cyclosilicate (ZS) 10g
Drug: Placebo
Enrollment 103
Recruitment Details Patients not receiving any therapy for hyperkalaemia and with 2 consecutive potassium values of ≥ 5.1 millimoles/litre (mmol/L) and ≤ 6.5 mmol/L (as measured by i-STAT, a portable blood analyser) were enrolled into 24 study sites in Japan from June 2017 to February 2018.
Pre-assignment Details 103 patients were randomised 1:1:1 to receive double-blind treatment of sodium zirconium cyclosilicate (ZS) 5 grams (g) three times daily (TID), ZS 10 g TID, or placebo TID for 48 hours.
Arm/Group Title ZS 5 g TID ZS 10 g TID Placebo TID
Hide Arm/Group Description ZS suspension was administered 5 g orally TID for 48 hours. ZS suspension was administered 10 g orally TID for 48 hours. Placebo suspension was administered orally TID for 48 hours.
Period Title: Overall Study
Started 34 36 33
Completed 34 36 31
Not Completed 0 0 2
Reason Not Completed
Study-specific withdrawal criteria             0             0             2
Arm/Group Title ZS 5 g TID ZS 10 g TID Placebo TID Total
Hide Arm/Group Description ZS suspension was administered 5 g orally TID for 48 hours. ZS suspension was administered 10 g orally TID for 48 hours. Placebo suspension was administered orally TID for 48 hours. Total of all reporting groups
Overall Number of Baseline Participants 34 36 33 103
Hide Baseline Analysis Population Description
The full analysis set included all patients randomised in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 36 participants 33 participants 103 participants
72.4  (7.9) 71.1  (7.6) 76.1  (6.8) 73.2  (7.7)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 36 participants 33 participants 103 participants
<55 years 0 1 0 1
55 to 64 years 7 4 1 12
≥65 years 27 31 32 90
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 36 participants 33 participants 103 participants
Female
8
  23.5%
8
  22.2%
10
  30.3%
26
  25.2%
Male
26
  76.5%
28
  77.8%
23
  69.7%
77
  74.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 36 participants 33 participants 103 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
34
 100.0%
36
 100.0%
33
 100.0%
103
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 36 participants 33 participants 103 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
34
 100.0%
36
 100.0%
33
 100.0%
103
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Exponential Rate of Change in Serum Potassium (S-K) Values During the Initial 48 Hours of Study Drug Treatment
Hide Description

Blood samples for determination of potassium were collected pre-dose, and at 1, 2, and 4 hours post Dose 1 on Day 1. An additional sample was collected at 90 minutes post Dose 2 on Day 1 if i-STAT potassium values at the 4-hour post Dose 1 time point was ≥ 6.1 or <4.0 mmol/L. On Day 2 samples were analysed pre-dose, and 1 and 4 hours post Dose 1. S-K levels were analysed at the Central Laboratory.

Natural logarithm of S-K from 0 to 48 hours post dose are modelled by the random coefficients model including fixed effects of intercept, time, time x treatment and patient-level random effects for time and intercept. Exponential rate of change refers to the slope estimate from the random coefficients model.

Time Frame From 0 to 48 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all patients randomised in the study.
Arm/Group Title ZS 5 g TID ZS 10 g TID Placebo TID
Hide Arm/Group Description:
ZS suspension was administered 5 g orally TID for 48 hours.
ZS suspension was administered 10 g orally TID for 48 hours.
Placebo suspension was administered orally TID for 48 hours.
Overall Number of Participants Analyzed 34 36 33
Mean (Standard Error)
Unit of Measure: log (mmol/L) / hour
-0.00273  (0.000276) -0.00508  (0.000269) -0.00012  (0.000288)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ZS 10 g TID, Placebo TID
Comments Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).
Method of Estimation Estimation Parameter Treatment difference in slopes
Estimated Value -0.00496
Confidence Interval (2-Sided) 95%
-0.00571 to -0.00420
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.000380
Estimation Comments Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ZS 5 g TID, Placebo TID
Comments Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).
Method of Estimation Estimation Parameter Treatment difference in slopes
Estimated Value -0.00261
Confidence Interval (2-Sided) 95%
-0.00337 to -0.00185
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.000385
Estimation Comments Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.
2.Secondary Outcome
Title Percentage of Patients Who Achieved Normokalaemia at 48 Hours
Hide Description The percentage of patients who achieved normokalaemia (normalisation of S-K values to between 3.5 mmol/L and 5.0 mmol/L, inclusive) at 48 hours after start of dosing was determined. Patients with missing S-K values at 48 hours were regarded as not normokalaemic.
Time Frame At 48 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all patients randomised in the study.
Arm/Group Title ZS 5 g TID ZS 10g TID Placebo TID
Hide Arm/Group Description:
ZS suspension was administered 5 g orally TID for 48 hours.
ZS suspension was administered 10 g orally TID for 48 hours.
Placebo suspension was administered orally TID for 48 hours.
Overall Number of Participants Analyzed 34 36 33
Measure Type: Number
Unit of Measure: Percentage of Patients
85.3 91.7 15.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ZS 5 g TID, Placebo TID
Comments Logistic regression model including treatment and baseline S-K as explanatory variables was used.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 46.495
Confidence Interval (2-Sided) 95%
10.142 to 213.152
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ZS 10g TID, Placebo TID
Comments Logistic regression model including treatment and baseline S-K as explanatory variables was used.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 71.835
Confidence Interval (2-Sided) 95%
13.497 to 382.337
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Exponential Rate of Change in S-K Values During the Initial 24 Hours of Study Drug Treatment
Hide Description Blood samples for determination of potassium were collected pre-dose, and at 1, 2, and 4 hours post Dose 1 on Day 1. An additional sample was collected at 90 minutes post Dose 2 on Day 1 if i-STAT potassium values at the 4-hour post Dose 1 time point was ≥ 6.1 or <4.0 mmol/L. On Day 2 samples were analysed pre-dose, and 1 and 4 hours post Dose 1. S-K levels were analysed at the Central Laboratory. Natural logarithm of S-K from 0 to 24 hours post dose are modelled by the random coefficients model including fixed effects of intercept, time, time x treatment and patient-level random effects for time and intercept. Exponential rate of change refers to the slope estimate from the random coefficients model.
Time Frame From 0 to 24 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all patients randomised in the study.
Arm/Group Title ZS 5 g TID ZS 10 g TID Placebo TID
Hide Arm/Group Description:
ZS suspension was administered 5 g orally TID for 48 hours.
ZS suspension was administered 10 g orally TID for 48 hours.
Placebo suspension was administered orally TID for 48 hours.
Overall Number of Participants Analyzed 34 36 33
Mean (Standard Error)
Unit of Measure: log (mmol/L) / hour
-0.00234  (0.000468) -0.00403  (0.000457) -0.00002  (0.000489)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ZS 5 g TID, Placebo TID
Comments Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference in slopes
Estimated Value -0.00231
Confidence Interval (2-Sided) 95%
-0.00359 to -0.00104
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.000645
Estimation Comments Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ZS 10 g TID, Placebo TID
Comments Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference in slopes
Estimated Value -0.00401
Confidence Interval (2-Sided) 95%
-0.00527 to -0.00275
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.000637
Estimation Comments Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.
4.Secondary Outcome
Title Percentage of Patients Who Achieved Normokalaemia at 24 Hours
Hide Description The percentage of patients who achieved normokalaemia (normalisation of S-K values to between 3.5 mmol/L and 5.0 mmol/L, inclusive) at 24 hours after start of dosing was determined. Patients with missing S-K values at 24 hours were regarded as not normokalaemic.
Time Frame At 24 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all patients randomised in the study.
Arm/Group Title ZS 5 g TID ZS 10g TID Placebo TID
Hide Arm/Group Description:
ZS suspension was administered 5 g orally TID for 48 hours.
ZS suspension was administered 10 g orally TID for 48 hours.
Placebo suspension was administered orally TID for 48 hours.
Overall Number of Participants Analyzed 34 36 33
Measure Type: Number
Unit of Measure: Percentage of Patients
35.3 83.3 27.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ZS 5 g TID, Placebo TID
Comments Logistic regression model including treatment and baseline S-K as explanatory variables was used.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6167
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.347
Confidence Interval (2-Sided) 95%
0.419 to 4.329
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ZS 10g TID, Placebo TID
Comments Logistic regression model including treatment and baseline S-K as explanatory variables was used.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 15.334
Confidence Interval (2-Sided) 95%
4.006 to 58.697
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Patients Who Achieved Normokalaemia at Each Scheduled Potassium Assessment Time Point
Hide Description The percentage of patients who achieved normokalaemia (normalisation of S-K values to between 3.5 mmol/L and 5.0 mmol/L, inclusive) at each each scheduled potassium assessment time point after the start of dosing was determined. Patients with missing S-K values were regarded as not normokalaemic.
Time Frame From baseline to end of study (9 days).
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all patients randomised in the study.
Arm/Group Title ZS 5 g TID ZS 10g TID Placebo TID
Hide Arm/Group Description:
ZS suspension was administered 5 g orally TID for 48 hours.
ZS suspension was administered 10 g orally TID for 48 hours.
Placebo suspension was administered orally TID for 48 hours.
Overall Number of Participants Analyzed 34 36 33
Measure Type: Number
Unit of Measure: Percentage of Patients
Baseline 2.9 5.6 0.0
1 hour after first dose 29.4 47.2 21.2
2 hours after first dose 41.2 58.3 42.4
4 hours after first dose 44.1 63.9 42.4
24 hours after first dose 35.3 83.3 27.3
25 hours after first dose 73.5 97.2 18.2
28 hours after first dose 67.6 97.2 36.4
48 hours after first dose 85.3 91.7 15.2
End of study (Last dose + 7 days) 55.9 61.1 27.3
6.Secondary Outcome
Title Mean Change From Baseline in S-K Values at All Measured Time Intervals
Hide Description Blood samples for determination of potassium were collected pre-dose, and at 1, 2, and 4 hours post Dose 1 on Day 1. An additional sample was collected at 90 minutes post Dose 2 on Day 1 if i-STAT potassium values at the 4-hour post Dose 1 time point was ≥ 6.1 or <4.0 mmol/L. On Day 2 samples were analysed pre-dose, and 1 and 4 hours post Dose 1. S-K levels were analysed locally using i-STAT devices, and at the Central Laboratory. S-K values measured at each time point and end of study visit were recorded and mean change from baseline is displayed.
Time Frame From baseline to end of study (9 days).
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all patients randomised in the study.
Arm/Group Title ZS 5 g TID ZS 10g TID Placebo TID
Hide Arm/Group Description:
ZS suspension was administered 5 g orally TID for 48 hours.
ZS suspension was administered 10 g orally TID for 48 hours.
Placebo suspension was administered orally TID for 48 hours.
Overall Number of Participants Analyzed 34 36 33
Mean (Standard Deviation)
Unit of Measure: mmol/L
1 hour after first dose Number Analyzed 34 participants 36 participants 33 participants
-0.20  (0.34) -0.37  (0.35) -0.13  (0.32)
2 hours after first dose Number Analyzed 34 participants 36 participants 32 participants
-0.41  (0.28) -0.50  (0.40) -0.33  (0.30)
4 hours after first dose Number Analyzed 34 participants 36 participants 32 participants
-0.40  (0.32) -0.53  (0.36) -0.43  (0.31)
24 hours after first dose Number Analyzed 34 participants 36 participants 31 participants
-0.51  (0.30) -0.69  (0.38) -0.22  (0.35)
25 hours after first dose Number Analyzed 34 participants 36 participants 31 participants
-0.74  (0.31) -1.00  (0.45) -0.27  (0.31)
28 hours after first dose Number Analyzed 34 participants 36 participants 31 participants
-0.72  (0.35) -1.12  (0.39) -0.41  (0.43)
48 hours after first dose Number Analyzed 34 participants 36 participants 31 participants
-0.83  (0.31) -1.30  (0.48) -0.24  (0.34)
End of study (Last dose + 7 days) Number Analyzed 34 participants 36 participants 33 participants
-0.56  (0.38) -0.66  (0.52) -0.20  (0.59)
7.Secondary Outcome
Title Mean Percent Change From Baseline in S-K Values at All Measured Time Intervals
Hide Description Blood samples for determination of potassium were collected pre-dose, and at 1, 2, and 4 hours post Dose 1 on Day 1. An additional sample was collected at 90 minutes post Dose 2 on Day 1 if i-STAT potassium values at the 4-hour post Dose 1 time point was ≥ 6.1 or <4.0 mmol/L. On Day 2 samples were analysed pre-dose, and 1 and 4 hours post Dose 1. S-K levels were analysed locally using i-STAT devices, and at the Central Laboratory. S-K values measured at each time point and end of study visit were recorded and mean percent change from baseline is displayed.
Time Frame From baseline to end of study (9 days).
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all patients randomised in the study.
Arm/Group Title ZS 5 g TID ZS 10g TID Placebo TID
Hide Arm/Group Description:
ZS suspension was administered 5 g orally TID for 48 hours.
ZS suspension was administered 10 g orally TID for 48 hours.
Placebo suspension was administered orally TID for 48 hours.
Overall Number of Participants Analyzed 34 36 33
Mean (Standard Deviation)
Unit of Measure: Percent change
1 hour after first dose Number Analyzed 34 participants 36 participants 33 participants
-3.61  (6.28) -6.72  (6.29) -2.32  (5.60)
2 hours after first dose Number Analyzed 34 participants 36 participants 32 participants
-7.46  (5.04) -9.07  (6.88) -6.06  (5.40)
4 hours after first dose Number Analyzed 34 participants 36 participants 32 participants
-7.08  (5.65) -9.70  (6.53) -7.77  (5.62)
24 hours after first dose Number Analyzed 34 participants 36 participants 31 participants
-8.98  (5.33) -12.51  (6.30) -3.81  (6.24)
25 hours after first dose Number Analyzed 34 participants 36 participants 31 participants
-13.20  (5.42) -18.06  (7.05) -4.77  (5.66)
28 hours after first dose Number Analyzed 34 participants 36 participants 31 participants
-12.90  (6.10) -20.47  (6.38) -7.21  (7.61)
48 hours after first dose Number Analyzed 34 participants 36 participants 31 participants
-14.81  (5.08) -23.64  (8.27) -4.06  (5.93)
End of study (Last dose + 7 days) Number Analyzed 34 participants 36 participants 33 participants
-9.85  (6.51) -11.89  (9.07) -3.15  (9.99)
8.Secondary Outcome
Title Time to Normalisation in S-K Values
Hide Description The distribution of time to normalisation of S-K values (defined as S-K values between 3.5 mmol/L and 5.0 mmol/L, inclusive) was measured. A patient who reached at least one S-K within normal range was counted as an event regardless of S-K value after that time point. Patients who did not achieve normokalaemia within 48 hours were censored.
Time Frame From 0 to 48 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all patients randomised in the study.
Arm/Group Title ZS 5g TID ZS 10g TID Placebo TID
Hide Arm/Group Description:
ZS suspension was administered 5 g orally TID for 48 hours.
ZS suspension was administered 10 g orally TID for 48 hours.
Placebo suspension was administered orally TID for 48 hours.
Overall Number of Participants Analyzed 34 36 33
Median (95% Confidence Interval)
Unit of Measure: Hours
3.883
(1.767 to 23.083)
1.758
(1.000 to 3.967)
3.867 [1] 
(1.917 to NA)
[1]
Upper limit not reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ZS 5g TID, Placebo TID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0586
Comments Nominal p value
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ZS 10g TID, Placebo TID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments Nominal p value
Method Log Rank
Comments [Not Specified]
9.Secondary Outcome
Title Time to a Decrease in S-K Levels of 0.5 mmol/L
Hide Description The median time (hours) for S-K values to decrease by 0.5 mmol/L was measured.
Time Frame From 0 to 48 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all patients randomised in the study.
Arm/Group Title ZS 5g TID ZS 10g TID Placebo TID
Hide Arm/Group Description:
ZS suspension was administered 5 g orally TID for 48 hours.
ZS suspension was administered 10 g orally TID for 48 hours.
Placebo suspension was administered orally TID for 48 hours.
Overall Number of Participants Analyzed 34 36 33
Median (95% Confidence Interval)
Unit of Measure: Hours
3.883
(1.933 to 19.767)
2.892
(1.083 to 4.100)
4.050
(1.983 to 23.667)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ZS 5g TID, Placebo TID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0250
Comments Nominal p value
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ZS 10g TID, Placebo TID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0064
Comments Nominal p value
Method Log Rank
Comments [Not Specified]
Time Frame Treatment-emergent adverse events (TEAEs) were reported from Day 1 to Day 3 inclusive.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ZS 5 g TID ZS 10 g TID Placebo TID
Hide Arm/Group Description ZS suspension was administered 5 g orally TID for 48 hours. ZS suspension was administered 10 g orally TID for 48 hours. Placebo suspension was administered orally TID for 48 hours.
All-Cause Mortality
ZS 5 g TID ZS 10 g TID Placebo TID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)      0/36 (0.00%)      0/33 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
ZS 5 g TID ZS 10 g TID Placebo TID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      0/36 (0.00%)      0/33 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ZS 5 g TID ZS 10 g TID Placebo TID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/34 (11.76%)      5/36 (13.89%)      1/33 (3.03%)    
Blood and lymphatic system disorders       
Nephrogenic anaemia  1  1/34 (2.94%)  1 0/36 (0.00%)  0 0/33 (0.00%)  0
Cardiac disorders       
Ventricular extrasystoles  1  0/34 (0.00%)  0 1/36 (2.78%)  1 0/33 (0.00%)  0
Gastrointestinal disorders       
Constipation  1  1/34 (2.94%)  1 0/36 (0.00%)  0 0/33 (0.00%)  0
General disorders       
Thirst  1  1/34 (2.94%)  1 0/36 (0.00%)  0 0/33 (0.00%)  0
Infections and infestations       
Respiratory tract infection  1  0/34 (0.00%)  0 0/36 (0.00%)  0 1/33 (3.03%)  1
Viral upper respiratory tract infection  1  1/34 (2.94%)  1 0/36 (0.00%)  0 0/33 (0.00%)  0
Metabolism and nutrition disorders       
Hypoglycaemia  1  0/34 (0.00%)  0 1/36 (2.78%)  1 0/33 (0.00%)  0
Nervous system disorders       
Tension headache  1  0/34 (0.00%)  0 1/36 (2.78%)  1 0/33 (0.00%)  0
Tremor  1  0/34 (0.00%)  0 1/36 (2.78%)  5 0/33 (0.00%)  0
Skin and subcutaneous tissue disorders       
Erythema  1  0/34 (0.00%)  0 1/36 (2.78%)  1 0/33 (0.00%)  0
1
Term from vocabulary, MedDRA version 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
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Name/Title: Global Clinical Lead
Organization: AstraZeneca
Phone: +1 302 885 1180
EMail: ClinicalTrialTransparency@astrazeneca.com
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03127644     History of Changes
Other Study ID Numbers: D9482C00002
First Submitted: April 5, 2017
First Posted: April 25, 2017
Results First Submitted: February 20, 2019
Results First Posted: May 20, 2019
Last Update Posted: May 20, 2019