Trial Outcomes & Findings for Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia (NCT NCT03172702)
NCT ID: NCT03172702
Last Updated: 2020-05-01
Results Overview
The number of patients who experienced any AE, including those which were serious (SAE), had an outcome of death, were severe, led to discontinuation of ZS or were causally related to ZS are presented for the MP. AEs of special interest are also presented, including oedema-related AEs, cardiac failure and hypertension.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
First MP dose up to 1 day (2 days for QOD regimen) after last MP dose.
Results posted on
2020-05-01
Participant Flow
Japanese patients with hyperkalemia were recruited to this open-label, single-arm study with a flexible dosing regimen conducted in 44 study centers in Japan. First patient enrolled in September 2017; last patient completed in July 2019.
For inclusion, patients were required to have 2 consecutive iSTAT (portable blood analyzer) potassium values, measured 60 minutes apart, both ≥5.1 millimole per liter (mmol/L) and measured within 1 day before the first dose of sodium zirconium cyclosilicate (ZS) on Correction Phase (CP) Day 1.
Participant milestones
| Measure |
Sodium Zirconium Cyclosilicate
CP (up to 3 days):
Patients received 10 grams (g) ZS three times daily (TID) for a maximum of 72 hours. If a patient became normokalemic (iSTAT potassium ≥3.5 and ≤5.0 mmol/L) after 24, 48 or 72 hours they progressed to the Maintenance Phase (MP).
MP (up to 12 months):
Patients received a starting dose of 5 g ZS once daily (QD) and based on the iSTAT potassium measurements the ZS dose could be increased to 10 g or 15 g QD or decreased to 5 g once every other day (QOD) or 2.5 g QD.
|
|---|---|
|
Overall Study
STARTED
|
150
|
|
Overall Study
Received Treatment in CP
|
150
|
|
Overall Study
Received Treatment in MP
|
150
|
|
Overall Study
COMPLETED
|
122
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Sodium Zirconium Cyclosilicate
CP (up to 3 days):
Patients received 10 grams (g) ZS three times daily (TID) for a maximum of 72 hours. If a patient became normokalemic (iSTAT potassium ≥3.5 and ≤5.0 mmol/L) after 24, 48 or 72 hours they progressed to the Maintenance Phase (MP).
MP (up to 12 months):
Patients received a starting dose of 5 g ZS once daily (QD) and based on the iSTAT potassium measurements the ZS dose could be increased to 10 g or 15 g QD or decreased to 5 g once every other day (QOD) or 2.5 g QD.
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Death
|
2
|
|
Overall Study
Study-specific Withdrawal Criteria
|
10
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia
Baseline characteristics by cohort
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
150 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First MP dose up to 1 day (2 days for QOD regimen) after last MP dose.Population: The safety analysis set for the MP (SAF-MP) included all patients treated with at least 1 dose of MP ZS and who had any MP safety data.
The number of patients who experienced any AE, including those which were serious (SAE), had an outcome of death, were severe, led to discontinuation of ZS or were causally related to ZS are presented for the MP. AEs of special interest are also presented, including oedema-related AEs, cardiac failure and hypertension.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Number of Patients Who Experienced Adverse Events (AEs) in the MP
Any AE
|
131 Participants
|
|
Number of Patients Who Experienced Adverse Events (AEs) in the MP
Any AE with outcome death
|
2 Participants
|
|
Number of Patients Who Experienced Adverse Events (AEs) in the MP
Any SAE
|
27 Participants
|
|
Number of Patients Who Experienced Adverse Events (AEs) in the MP
Any severe AE
|
9 Participants
|
|
Number of Patients Who Experienced Adverse Events (AEs) in the MP
Any AE leading to ZS discontinuation
|
12 Participants
|
|
Number of Patients Who Experienced Adverse Events (AEs) in the MP
Any causally related AE
|
30 Participants
|
|
Number of Patients Who Experienced Adverse Events (AEs) in the MP
Oedema-related AE
|
31 Participants
|
|
Number of Patients Who Experienced Adverse Events (AEs) in the MP
Cardiac failure
|
10 Participants
|
|
Number of Patients Who Experienced Adverse Events (AEs) in the MP
Hypertension
|
24 Participants
|
SECONDARY outcome
Timeframe: MP Day 1 to End of Study visit (up to 12 months).Population: The full analysis set for the MP (FAS-MP) included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.
The percentage of patients who were normokalemic at each study visit in the MP is presented. Normokalemia was defined as a serum potassium (S-K) level of ≥ 3.5 and ≤ 5.0 mmol/L. The percentage of patients who were normokalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 1
|
82.0 Percentage of patients
Interval 74.9 to 87.8
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 2
|
78.7 Percentage of patients
Interval 71.2 to 84.9
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 5
|
79.9 Percentage of patients
Interval 72.5 to 86.0
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 12
|
67.8 Percentage of patients
Interval 59.6 to 75.2
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 19
|
65.5 Percentage of patients
Interval 57.3 to 73.2
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 26
|
72.3 Percentage of patients
Interval 64.3 to 79.3
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 54
|
76.4 Percentage of patients
Interval 68.6 to 83.1
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 82
|
72.1 Percentage of patients
Interval 63.9 to 79.4
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 110
|
75.9 Percentage of patients
Interval 67.9 to 82.8
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 138
|
85.1 Percentage of patients
Interval 77.9 to 90.6
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 166
|
78.0 Percentage of patients
Interval 70.0 to 84.8
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 194
|
75.4 Percentage of patients
Interval 67.1 to 82.5
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 222
|
70.5 Percentage of patients
Interval 61.9 to 78.2
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 250
|
79.8 Percentage of patients
Interval 71.9 to 86.4
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 278
|
75.6 Percentage of patients
Interval 67.2 to 82.8
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 306
|
74.2 Percentage of patients
Interval 65.6 to 81.6
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 334
|
83.1 Percentage of patients
Interval 75.3 to 89.2
|
|
Percentage of Patients Who Were Normokalemic in the MP
MP Day 362
|
79.5 Percentage of patients
Interval 71.3 to 86.3
|
|
Percentage of Patients Who Were Normokalemic in the MP
Last on-treatment Visit
|
78.0 Percentage of patients
Interval 70.5 to 84.3
|
|
Percentage of Patients Who Were Normokalemic in the MP
End of Study Visit
|
38.4 Percentage of patients
Interval 30.4 to 46.8
|
SECONDARY outcome
Timeframe: MP Day 2 to Day 362.Population: The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.
The percentage of patients who had an average S-K level of ≤5.1 mmol/L and ≤5.5 mmol/L over the MP up to Day 362 is presented.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Percentage of Patients With Average S-K Levels of ≤5.1 mmol/L and ≤5.5 mmol/L in the MP
≤5.1 mmol/L
|
93.3 Percentage of patients
Interval 88.1 to 96.8
|
|
Percentage of Patients With Average S-K Levels of ≤5.1 mmol/L and ≤5.5 mmol/L in the MP
≤5.5 mmol/L
|
100.0 Percentage of patients
Interval 97.6 to 100.0
|
SECONDARY outcome
Timeframe: MP Day 1 to End of Study visit (up to 12 months).Population: The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.
The percentage of patients who were hypokalemic at each study visit in the MP is presented. Hypokalemia was defined as a S-K level of \< 3.5 mmol/L. The percentage of patients who were hypokalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 1
|
0.0 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 2
|
0.0 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 5
|
0.0 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
Day 12
|
0.0 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 19
|
0.0 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 26
|
0.7 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 54
|
2.8 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 82
|
3.6 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 110
|
0.7 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 138
|
2.2 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 166
|
1.5 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 194
|
0.8 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 222
|
1.6 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 250
|
2.3 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 278
|
1.6 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 306
|
1.6 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 334
|
1.6 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
MP Day 362
|
1.6 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
Last on-treatment Visit
|
5.3 Percentage of patients
|
|
Percentage of Patients Who Were Hypokalemic in the MP
End of Study Visit
|
0.7 Percentage of patients
|
SECONDARY outcome
Timeframe: MP Day 1 to End of Study visit (up to 12 months).Population: The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.
The percentage of patients who were hyperkalemic at each study visit in the MP is presented. Hyperkalemia was defined as a S-K level of \>5.0 mmol/L. The percentage of patients who were hyperkalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 5
|
20.1 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 1
|
18.0 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 2
|
21.3 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 12
|
32.2 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 19
|
34.5 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 26
|
27.0 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 54
|
20.8 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 82
|
24.3 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 110
|
23.4 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 138
|
12.7 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 166
|
20.5 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 194
|
23.8 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 222
|
27.9 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 250
|
17.8 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 278
|
22.8 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 306
|
24.2 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 334
|
15.3 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
MP Day 362
|
18.9 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
Last on-treatment Visit
|
16.7 Percentage of patients
|
|
Percentage of Patients Who Were Hyperkalemic in the MP
End of Study Visit
|
61.0 Percentage of patients
|
SECONDARY outcome
Timeframe: CP Day 1 to MP Day 362.Population: The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.
The mean changes from the CP baseline in S-K level over specified periods of time in the MP are presented. Baseline for the CP was defined as the mean of 2 different S-K values, recorded 60 minutes apart (to confirm qualification for study entry) on the CP Day 1.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
MP Day 1
|
-0.93 mmol/L
Standard Deviation 0.44
|
|
Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
Entire MP (Day 2 to Day 362)
|
-0.98 mmol/L
Standard Deviation 0.42
|
|
Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
MP Day 82 to Day 362
|
-1.07 mmol/L
Standard Deviation 0.52
|
|
Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
MP Day 2 to Day 82
|
-0.91 mmol/L
Standard Deviation 0.41
|
|
Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
MP Day 110 to Day 166
|
-1.11 mmol/L
Standard Deviation 0.61
|
|
Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
MP Day 194 to Day 278
|
-1.01 mmol/L
Standard Deviation 0.51
|
|
Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
MP Day 306 to Day 362
|
-1.06 mmol/L
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: MP Day 1 to Day 362.Population: The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.
The mean changes from the MP baseline in S-K level over specified periods of time in the MP are presented. Baseline for the MP was defined as the measurement taken in the morning of the day of entering the MP (MP Day 1).
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Mean Change From MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
Entire MP (Day 2 to Day 362)
|
-0.07 mmol/L
Standard Deviation 0.33
|
|
Mean Change From MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
MP Day 82 to Day 362
|
-0.14 mmol/L
Standard Deviation 0.42
|
|
Mean Change From MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
MP Day 2 to Day 82
|
-0.01 mmol/L
Standard Deviation 0.36
|
|
Mean Change From MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
MP Day 110 to Day 166
|
-0.16 mmol/L
Standard Deviation 0.50
|
|
Mean Change From MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
MP Day 194 to Day 278
|
-0.07 mmol/L
Standard Deviation 0.42
|
|
Mean Change From MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
MP Day 306 to Day 362
|
-0.11 mmol/L
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: MP Day 1 to Day 362.Population: The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.
The number of normokalemic days during the MP was calculated assuming the time interval between assessments was normokalemic if both the beginning and end assessments for that time interval displayed normal S-K values. If an intermediate scheduled assessment time point was missing, then the scheduled assessment was regarded as not normokalemic. The mean number of normokalemic days for a patient in the MP is presented.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Mean Number of Normokalemic Days During the MP
|
207.7 Days
Standard Deviation 109.5
|
SECONDARY outcome
Timeframe: MP Day 1 to End of Study visit (up to 12 months).Population: The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.
The mean change in the S-K level from the last on-treatment MP visit to the End of Study is presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Mean Change in S-K Level From Last On-treatment MP Visit to the End of Study
|
0.66 mmol/L
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: CP Day 1, MP Day 166 and MP Day 362.Population: The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.
The mean change from CP baseline to MP Day 166 and MP Day 362 in S-aldosterone levels is presented. In addition, the mean change from CP baseline to the last on-treatment value is presented. The CP baseline was defined as the last S-aldosterone assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Change From CP Baseline in S-Aldosterone Levels Over the MP
MP Day 166
|
-56.355 Picomole per liter (pmol/L)
Standard Deviation 124.050
|
|
Change From CP Baseline in S-Aldosterone Levels Over the MP
MP Day 362
|
-48.561 Picomole per liter (pmol/L)
Standard Deviation 129.261
|
|
Change From CP Baseline in S-Aldosterone Levels Over the MP
Last on-treatment Visit
|
-48.808 Picomole per liter (pmol/L)
Standard Deviation 125.081
|
SECONDARY outcome
Timeframe: CP Day 1, MP Day 166 and MP Day 362.Population: The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.
The percentage of patients with normal S-aldosterone levels up to Day 362 of the MP is presented. The normal range for S-aldosterone was 0 - 776.72 pmol/L. In addition, the percentage of patients with normal S-aldosterone levels at the last on-treatment visit is presented. The CP baseline was defined as the last S-aldosterone assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Percentage of Patients With Normal S-Aldosterone Levels Over the MP
CP Baseline
|
99.3 Percentage of patients
Interval 96.3 to 100.0
|
|
Percentage of Patients With Normal S-Aldosterone Levels Over the MP
MP Day 166
|
100.0 Percentage of patients
Interval 97.2 to 100.0
|
|
Percentage of Patients With Normal S-Aldosterone Levels Over the MP
MP Day 362
|
100.0 Percentage of patients
Interval 97.0 to 100.0
|
|
Percentage of Patients With Normal S-Aldosterone Levels Over the MP
Last on-treatment Visit
|
100.0 Percentage of patients
Interval 97.2 to 100.0
|
SECONDARY outcome
Timeframe: CP Day 1, and MP Day 1 to End of Study visit (up to 12 months).Population: The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.
The mean change from CP baseline to timepoints in the MP in S-bicarbonate levels is presented. In addition, the mean change from CP baseline to the last on-treatment value is presented. The CP baseline was defined as the last S-bicarbonate assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Change From CP Baseline in S-Bicarbonate Levels Over the MP
MP Day 250
|
1.84 mmol/L
Standard Deviation 2.64
|
|
Change From CP Baseline in S-Bicarbonate Levels Over the MP
MP Day 1
|
1.20 mmol/L
Standard Deviation 1.64
|
|
Change From CP Baseline in S-Bicarbonate Levels Over the MP
MP Day 5
|
1.20 mmol/L
Standard Deviation 1.71
|
|
Change From CP Baseline in S-Bicarbonate Levels Over the MP
MP Day 12
|
1.46 mmol/L
Standard Deviation 1.91
|
|
Change From CP Baseline in S-Bicarbonate Levels Over the MP
MP Day 19
|
1.29 mmol/L
Standard Deviation 2.27
|
|
Change From CP Baseline in S-Bicarbonate Levels Over the MP
MP Day 26
|
1.64 mmol/L
Standard Deviation 2.22
|
|
Change From CP Baseline in S-Bicarbonate Levels Over the MP
MP Day 82
|
1.45 mmol/L
Standard Deviation 2.90
|
|
Change From CP Baseline in S-Bicarbonate Levels Over the MP
MP Day 166
|
1.55 mmol/L
Standard Deviation 2.53
|
|
Change From CP Baseline in S-Bicarbonate Levels Over the MP
MP Day 334
|
1.73 mmol/L
Standard Deviation 2.75
|
|
Change From CP Baseline in S-Bicarbonate Levels Over the MP
MP Day 362
|
1.50 mmol/L
Standard Deviation 2.85
|
|
Change From CP Baseline in S-Bicarbonate Levels Over the MP
Last on-treatment Visit
|
1.70 mmol/L
Standard Deviation 2.87
|
|
Change From CP Baseline in S-Bicarbonate Levels Over the MP
End of Study Visit
|
0.55 mmol/L
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: CP Day 1 and MP Day 1 to End of Study visit (up to 12 months).Population: The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.
The percentage of patients with normal S-bicarbonate levels up to the End of Study visit in the MP is presented. The normal range for S-bicarbonate was 17 - 32 mmol/L. In addition, the percentage of patients with normal S-bicarbonate levels at the last on-treatment visit is presented. The CP baseline was defined as the last S-bicarbonate assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
CP Baseline
|
90.0 Percentage of patients
Interval 84.0 to 94.3
|
|
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
MP Day 1
|
98.0 Percentage of patients
Interval 94.2 to 99.6
|
|
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
MP Day 5
|
98.6 Percentage of patients
Interval 95.2 to 99.8
|
|
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
MP Day 12
|
98.0 Percentage of patients
Interval 94.2 to 99.6
|
|
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
MP Day 19
|
97.3 Percentage of patients
Interval 93.2 to 99.3
|
|
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
MP Day 26
|
98.6 Percentage of patients
Interval 95.2 to 99.8
|
|
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
MP Day 82
|
97.8 Percentage of patients
Interval 93.8 to 99.6
|
|
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
MP Day 166
|
99.2 Percentage of patients
Interval 95.9 to 100.0
|
|
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
MP Day 250
|
99.2 Percentage of patients
Interval 95.8 to 100.0
|
|
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
MP Day 334
|
97.6 Percentage of patients
Interval 93.1 to 99.5
|
|
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
MP Day 362
|
95.9 Percentage of patients
Interval 90.7 to 98.7
|
|
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
Last on-treatment Visit
|
96.7 Percentage of patients
Interval 92.4 to 98.9
|
|
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
End of Study Visit
|
93.8 Percentage of patients
Interval 88.6 to 97.1
|
SECONDARY outcome
Timeframe: CP Day 1 (baseline) and MP Day 362 (post-baseline).Population: The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.
Patients completed the SF-36 v2 questionnaire on Day 1 of the CP and on Day 362 of the MP. The responses to the items assessing the physical and mental health of the patients determined the PCS and MCS based on a standard algorithm. The PCS and MCS scores ranged from 0 (worst possible health state) to 100 (best possible health state). The mean PCS and MCS are presented for the baseline and post-baseline assessments.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Baseline and Post-baseline 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
Baseline: PCS
|
49.106 Scale score
Standard Deviation 6.292
|
|
Baseline and Post-baseline 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
Post-baseline: PCS
|
49.348 Scale score
Standard Deviation 6.659
|
|
Baseline and Post-baseline 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
Baseline: MCS
|
51.126 Scale score
Standard Deviation 8.375
|
|
Baseline and Post-baseline 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
Post-baseline: MCS
|
50.350 Scale score
Standard Deviation 8.384
|
SECONDARY outcome
Timeframe: CP Day 1 to Day 3.Population: The CP full analysis set (FAS-CP) included all patients who received at least 1 dose of ZS during the CP and who had any post-baseline CP S-K values.
The mean change from the CP baseline at 24, 48 and 72 hours in the CP is presented. The mean change from baseline to the last on-treatment CP value is also presented. The last on-treatment value was defined as the last measurement taken with 1 day (2 days if on the QOD regimen) after the last ZS dose. Baseline for the CP was defined as the mean of 2 different S-K values, recorded 60 minutes apart (to confirm qualification for study entry) on the CP Day 1.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Mean Change From CP Baseline in the Mean S-K Levels in the CP
24 hours
|
-0.78 mmol/L
Standard Deviation 0.39
|
|
Mean Change From CP Baseline in the Mean S-K Levels in the CP
48 hours
|
-1.30 mmol/L
Standard Deviation 0.39
|
|
Mean Change From CP Baseline in the Mean S-K Levels in the CP
72 hours
|
NA mmol/L
Standard Deviation NA
Data for a single patient not reported for data privacy reasons.
|
|
Mean Change From CP Baseline in the Mean S-K Levels in the CP
Last on-treatment Visit
|
-0.93 mmol/L
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: CP Day 1 to Day 3.Population: The FAS-CP included all patients who received at least 1 dose of ZS during the CP and who had any post-baseline CP S-K values.
The percentage of patients who were normokalemic at 24, 48 and 72 hours in the CP is presented. Normokalemia was defined as a S-K level of ≥ 3.5 and ≤ 5.0 mmol/L.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Percentage of Patients Who Were Normokalemic in the CP
24 hours
|
65.3 Percentage of patients
Interval 57.1 to 72.9
|
|
Percentage of Patients Who Were Normokalemic in the CP
48 hours
|
81.3 Percentage of patients
Interval 74.2 to 87.2
|
|
Percentage of Patients Who Were Normokalemic in the CP
72 hours
|
82.0 Percentage of patients
Interval 74.9 to 87.8
|
SECONDARY outcome
Timeframe: Day 1 of CP to last CP dose + 1 day or first MP dose -1 day, earlier.Population: The SAF-CP included all patients treated with at least 1 dose of CP ZS and who had any CP safety data.
The number of patients who experienced any AE, including SAEs, those which had an outcome of death, were severe, led to discontinuation of ZS or were causally related to ZS are presented for the CP. AEs of special interest are also presented, including oedema-related AEs, cardiac failure and hypertension.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate
n=150 Participants
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|
|
Number of Patients Who Experienced AEs in the CP
Any AE
|
5 Participants
|
|
Number of Patients Who Experienced AEs in the CP
Any AE with outcome death
|
0 Participants
|
|
Number of Patients Who Experienced AEs in the CP
Any SAE
|
1 Participants
|
|
Number of Patients Who Experienced AEs in the CP
Any severe AE
|
0 Participants
|
|
Number of Patients Who Experienced AEs in the CP
Any AE leading to ZS discontinuation
|
0 Participants
|
|
Number of Patients Who Experienced AEs in the CP
Any causally related AE
|
0 Participants
|
|
Number of Patients Who Experienced AEs in the CP
Oedema-related AE
|
0 Participants
|
|
Number of Patients Who Experienced AEs in the CP
Cardiac failure
|
0 Participants
|
|
Number of Patients Who Experienced AEs in the CP
Hypertension
|
0 Participants
|
Adverse Events
Correction Phase
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Maintenance Phase
Serious events: 27 serious events
Other events: 79 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Correction Phase
n=150 participants at risk
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
|
Maintenance Phase
n=150 participants at risk
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
2.0%
3/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Undifferentiated sarcoma
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Eye disorders
Cataract
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
1.3%
2/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Eye disorders
Strabismus
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
2.7%
4/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
General disorders
Oedema peripheral
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
Other adverse events
| Measure |
Correction Phase
n=150 participants at risk
CP (up to 3 days):
Patients received 10 g ZS TID for a maximum of 72 hours.
|
Maintenance Phase
n=150 participants at risk
MP (up to 12 months):
Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.
|
|---|---|---|
|
General disorders
Oedema peripheral
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
15.3%
23/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Infections and infestations
Nasopharyngitis
|
0.67%
1/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
24.0%
36/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Vascular disorders
Hypertension
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
15.3%
23/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
13.3%
20/150 • For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place