Trial Outcomes & Findings for Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease (NCT NCT04727528)
NCT ID: NCT04727528
Last Updated: 2023-10-06
Results Overview
Response was defined as a subject having serum potassium (sK+) within 3.5-5.0 mmol/L at the EOT visit, and no use of rescue therapy for hyperkalaemia at any point during the randomized placebo-controlled period. Participants who used rescue therapy for hyperkalaemia at any point during the randomized placebo-controlled period were assigned a non-response. Participants who died prior to the EOT visit were treated as non-response. Participants who were lost to follow-up prior to the EOT visit had response treated as missing.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
39 participants
Primary outcome timeframe
Day 1 of randomization phase to Day 29
Results posted on
2023-10-06
Participant Flow
One participants was randomized to the double-blind treatment phase in error but did not receive treatment. This participant is noted as not completing the open-label phase in the table below.
Participant milestones
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours (not applicable in the open-label phase)
|
Placebo
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind placebo for up to 48 hours (not applicable in the open-label phase)
|
|---|---|---|
|
Open-label Period
STARTED
|
39
|
0
|
|
Open-label Period
COMPLETED
|
37
|
0
|
|
Open-label Period
NOT COMPLETED
|
2
|
0
|
|
Double-blind Treatment Phase
STARTED
|
17
|
20
|
|
Double-blind Treatment Phase
COMPLETED
|
16
|
15
|
|
Double-blind Treatment Phase
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours (not applicable in the open-label phase)
|
Placebo
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind placebo for up to 48 hours (not applicable in the open-label phase)
|
|---|---|---|
|
Open-label Period
Did not meet randomization criteria for double-blind treatment phase
|
1
|
0
|
|
Open-label Period
Randomized who did not receive treatment
|
1
|
0
|
|
Double-blind Treatment Phase
Adverse Event
|
0
|
1
|
|
Double-blind Treatment Phase
Death
|
0
|
1
|
|
Double-blind Treatment Phase
Missed doses whilst in hospital
|
0
|
1
|
|
Double-blind Treatment Phase
Investigator decision to start rescue therapy for hyperkalemia
|
0
|
1
|
|
Double-blind Treatment Phase
Physician Decision
|
0
|
1
|
|
Double-blind Treatment Phase
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Full Analysis Set
Baseline characteristics by cohort
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=17 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours
|
Placebo
n=20 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind placebo for up to 48 hours
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 16.77 • n=5 Participants
|
65.9 years
STANDARD_DEVIATION 11.13 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 14.09 • n=5 Participants
|
|
Age, Customized
>=85
|
0 Participants
n=5 Participants • Full Analysis Set
|
0 Participants
n=7 Participants • Full Analysis Set
|
0 Participants
n=5 Participants • Full Analysis Set
|
|
Age, Customized
18-64
|
9 Participants
n=5 Participants • Full Analysis Set
|
9 Participants
n=7 Participants • Full Analysis Set
|
18 Participants
n=5 Participants • Full Analysis Set
|
|
Age, Customized
65-84
|
8 Participants
n=5 Participants • Full Analysis Set
|
11 Participants
n=7 Participants • Full Analysis Set
|
19 Participants
n=5 Participants • Full Analysis Set
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants • Full Analysis Set
|
8 Participants
n=7 Participants • Full Analysis Set
|
12 Participants
n=5 Participants • Full Analysis Set
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants • Full Analysis Set
|
12 Participants
n=7 Participants • Full Analysis Set
|
25 Participants
n=5 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 Participants
n=5 Participants • Full Analysis Set
|
4 Participants
n=7 Participants • Full Analysis Set
|
10 Participants
n=5 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
11 Participants
n=5 Participants • Full Analysis Set
|
16 Participants
n=7 Participants • Full Analysis Set
|
27 Participants
n=5 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants • Full Analysis Set
|
0 Participants
n=7 Participants • Full Analysis Set
|
0 Participants
n=5 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants • Full Analysis Set
|
0 Participants
n=7 Participants • Full Analysis Set
|
0 Participants
n=5 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants • Full Analysis Set
|
1 Participants
n=7 Participants • Full Analysis Set
|
4 Participants
n=5 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Full Analysis Set
|
0 Participants
n=7 Participants • Full Analysis Set
|
0 Participants
n=5 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants • Full Analysis Set
|
1 Participants
n=7 Participants • Full Analysis Set
|
1 Participants
n=5 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants • Full Analysis Set
|
18 Participants
n=7 Participants • Full Analysis Set
|
32 Participants
n=5 Participants • Full Analysis Set
|
|
Diabetes status
No
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Diabetes status
Yes
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Chronic Kidney Disease (CKD) Status
Stage 3
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Chronic Kidney Disease (CKD) Status
Stage 4
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Chronic Kidney Disease (CKD) Status
Stage 5
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Chronic Kidney Disease (CKD) Status
Missing
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Chronic Heart Failure Status
No
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Chronic Heart Failure Status
Yes
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 of randomization phase to Day 29Population: Full analysis set
Response was defined as a subject having serum potassium (sK+) within 3.5-5.0 mmol/L at the EOT visit, and no use of rescue therapy for hyperkalaemia at any point during the randomized placebo-controlled period. Participants who used rescue therapy for hyperkalaemia at any point during the randomized placebo-controlled period were assigned a non-response. Participants who died prior to the EOT visit were treated as non-response. Participants who were lost to follow-up prior to the EOT visit had response treated as missing.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=17 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours
|
Placebo
n=20 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind placebo for up to 48 hours
|
|---|---|---|
|
Occurrence (Yes/no) of Participants Having Normal Serum Potassium (sK+) Between 3.5 and 5.0 mmol/L Inclusive at End of Treatment (EOT) Without Need for Rescue Treatment for Hyperkalemia at Any Point During the Randomized Phase
No response
|
1 Participants
|
15 Participants
|
|
Occurrence (Yes/no) of Participants Having Normal Serum Potassium (sK+) Between 3.5 and 5.0 mmol/L Inclusive at End of Treatment (EOT) Without Need for Rescue Treatment for Hyperkalemia at Any Point During the Randomized Phase
Response
|
15 Participants
|
4 Participants
|
|
Occurrence (Yes/no) of Participants Having Normal Serum Potassium (sK+) Between 3.5 and 5.0 mmol/L Inclusive at End of Treatment (EOT) Without Need for Rescue Treatment for Hyperkalemia at Any Point During the Randomized Phase
Missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 29Population: Full analysis set
Least-squares mean calculated with a repeated measures analysis of covariance model where the dependent variable was post randomization serum bicarbonate and with fixed terms for randomized treatment group and serum bicarbonate.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=16 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours
|
Placebo
n=17 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind placebo for up to 48 hours
|
|---|---|---|
|
Mean Serum Bicarbonate at Day 29
|
18.17 mmol/L
Standard Error 0.58
|
16.52 mmol/L
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Day 1 to Day 29 of randomization phasePopulation: Full analysis set
Occurrence (yes/no) of participants having an increase in serum bicarbonate of greater than or equal to 3 mmol/L from baseline (Day 1) to EOT (Day 29) without need for rescue treatment for metabolic acidosis (low bicarbonate). Response was defined as a participant with an increase in serum bicarbonate greater than or equal to 3 mmol/L at the EOT visit without the need for rescue therapy for low bicarbonate. Participants who used rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period had their last observation prior to rescue therapy carried forward. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=17 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours
|
Placebo
n=20 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind placebo for up to 48 hours
|
|---|---|---|
|
Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 3 mmol/L From Baseline to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate)
No response
|
10 Participants
|
16 Participants
|
|
Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 3 mmol/L From Baseline to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate)
Response
|
6 Participants
|
3 Participants
|
|
Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 3 mmol/L From Baseline to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate)
Missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 29 of randomization phasePopulation: Full analysis set
Response was defined as a participant with an increase in serum bicarbonate greater than or equal to 22 mmol/L at the EOT visit without the need for rescue therapy for low bicarbonate. Participants who had used rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period had their last observation prior to rescue therapy carried forward. Participants who died prior to the EOT visit were assigned a non-response. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=17 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours
|
Placebo
n=20 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind placebo for up to 48 hours
|
|---|---|---|
|
Occurrence (Yes/no) of Participants Having Serum Bicarbonate ≥22 mmol/L
No response
|
14 Participants
|
19 Participants
|
|
Occurrence (Yes/no) of Participants Having Serum Bicarbonate ≥22 mmol/L
Response
|
2 Participants
|
0 Participants
|
|
Occurrence (Yes/no) of Participants Having Serum Bicarbonate ≥22 mmol/L
Missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 29 of randomization phasePopulation: Full analysis set
Response was defined as a participant with an increase in serum bicarbonate greater than or equal to 2 mmol/L at the EOT visit and no use of rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period. Participants who used rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period had their last observation prior to rescue therapy carried forward. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=17 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours
|
Placebo
n=20 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind placebo for up to 48 hours
|
|---|---|---|
|
Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 2 mmol/L From Baseline (Day 1) to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate)
No response
|
8 Participants
|
13 Participants
|
|
Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 2 mmol/L From Baseline (Day 1) to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate)
Response
|
8 Participants
|
6 Participants
|
|
Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 2 mmol/L From Baseline (Day 1) to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate)
Missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 29 of randomization phasePopulation: Full analysis set
Participants with normal sK+ between 3.5 and 5.0 mmol/L inclusive at EOT and increase in serum bicarbonate greater than or equal to 3 mmol/L from Day 1 without rescue treatment for metabolic acidosis (low bicarbonate) or hyperkalemia. Response was a participant with sK+ within 3.5-5.0 mmol/L and increase in serum bicarbonate greater than or equal to 3 mmol/L at the EOT visit and no use of rescue therapy for hyperkalaemia or low bicarbonate at any point during the randomized placebo-controlled period. Participants who used rescue therapy for low bicarbonate or HK during the randomized placebo-controlled period had last observation prior to rescue therapy carried forward. Participants lost to follow-up prior to EOT visit had response as missing. Logistic regression model included response status (response/non-response) as dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=17 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours
|
Placebo
n=20 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind placebo for up to 48 hours
|
|---|---|---|
|
Participants Having Normal sK+ at EOT and an Increase in Serum Bicarbonate of ≥3 mmol/L From Baseline Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) or Hyperkalemia
No response
|
10 Participants
|
18 Participants
|
|
Participants Having Normal sK+ at EOT and an Increase in Serum Bicarbonate of ≥3 mmol/L From Baseline Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) or Hyperkalemia
Response
|
6 Participants
|
1 Participants
|
|
Participants Having Normal sK+ at EOT and an Increase in Serum Bicarbonate of ≥3 mmol/L From Baseline Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) or Hyperkalemia
Missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 29 of randomization phasePopulation: Full analysis set
Response was defined as a participant with sK+ within 3.5-5.0 mmol/L and serum bicarbonate greater than or equal to 22 mmol/L at the EOT visit without the need for rescue therapy for hyperkalaemia or low bicarbonate. Participants who used rescue therapy for hyperkalaemia or low bicarbonate at any point during the randomized placebo-controlled period were assigned a non-response. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=17 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours
|
Placebo
n=20 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind placebo for up to 48 hours
|
|---|---|---|
|
Occurrence (Yes/no) of Patients Having a Normal sK+ Between 3.5 and 5.0 mmol/L Inclusive and Bicarbonate ≥22 mmol/L at Day 29 Without Need for Rescue Treatment for Hyperkalemia or Metabolic Acidosis (Low Bicarbonate)
No response
|
14 Participants
|
19 Participants
|
|
Occurrence (Yes/no) of Patients Having a Normal sK+ Between 3.5 and 5.0 mmol/L Inclusive and Bicarbonate ≥22 mmol/L at Day 29 Without Need for Rescue Treatment for Hyperkalemia or Metabolic Acidosis (Low Bicarbonate)
Response
|
2 Participants
|
0 Participants
|
|
Occurrence (Yes/no) of Patients Having a Normal sK+ Between 3.5 and 5.0 mmol/L Inclusive and Bicarbonate ≥22 mmol/L at Day 29 Without Need for Rescue Treatment for Hyperkalemia or Metabolic Acidosis (Low Bicarbonate)
Missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 29 of randomization phasePopulation: Full analysis set
Occurrence (yes/no) of participants needing rescue treatment for low sodium bicarbonate any time during the randomized phase
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=17 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours
|
Placebo
n=20 Participants
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind placebo for up to 48 hours
|
|---|---|---|
|
Occurrence (Yes/no) of Participants Needing Rescue Treatment for Low Sodium Bicarbonate
Rescue treatment required
|
0 Participants
|
0 Participants
|
|
Occurrence (Yes/no) of Participants Needing Rescue Treatment for Low Sodium Bicarbonate
Rescue treatment not required
|
17 Participants
|
20 Participants
|
Adverse Events
Open-Label Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sodium Zirconium Cyclosilicate (SZC) Double-blind Treatment Phase
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Double-blind Treatment Phase
Serious events: 2 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Open-Label Phase
n=38 participants at risk
Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
|
Sodium Zirconium Cyclosilicate (SZC) Double-blind Treatment Phase
n=17 participants at risk
Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours
|
Placebo Double-blind Treatment Phase
n=20 participants at risk
Double-blind treatment phase: Double-blind placebo for up to 48 hours
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/20 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
Other adverse events
| Measure |
Open-Label Phase
n=38 participants at risk
Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
|
Sodium Zirconium Cyclosilicate (SZC) Double-blind Treatment Phase
n=17 participants at risk
Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours
|
Placebo Double-blind Treatment Phase
n=20 participants at risk
Double-blind treatment phase: Double-blind placebo for up to 48 hours
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/38 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
General disorders
Oedema peripheral
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
General disorders
Peripheral swelling
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.9%
1/17 • Number of events 2 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/20 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Infections and infestations
COVID-19
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/20 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
20.0%
4/20 • Number of events 4 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Nervous system disorders
Headache
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/20 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/20 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Eye disorders
Vision blurred
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/20 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/20 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/38 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
0.00%
0/17 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years of completion of the Study shall require the Sponsor's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER