Trial Outcomes & Findings for Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects (NCT NCT04217590)
NCT ID: NCT04217590
Last Updated: 2023-03-28
Results Overview
A subject was considered to be a responder if, during the evaluation period, they maintained a pre-dialysis serum potassium (S-K) between 4.0 and 5.0 mmol/L on at least 3 out of 4 dialysis treatments following the long inter-dialytic interval (LIDI) and did not receive rescue therapy. Subjects with no data during the evaluation period were classified as non-responders. The S-K levels used for this analysis were based on the measurements obtained by the central laboratory.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
134 participants
Primary outcome timeframe
Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.
Results posted on
2023-03-28
Participant Flow
The study has been completed and was conducted in 37 centres across China. 281 subjects were screened and 134 randomised subjects (67 per treatment group).
Eligbile Chinese subjects with end-stage renal disease (ESRD) on stable haemodialysis were randomly assigned to either sodium zirconium cyclosilicate (SZC) or placebo in a 1:1 ratio.
Participant milestones
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
Placebo
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
67
|
|
Overall Study
COMPLETED
|
63
|
64
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
Placebo
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
|---|---|---|
|
Overall Study
Other
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects
Baseline characteristics by cohort
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=67 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
Placebo
n=67 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.9 Years
STANDARD_DEVIATION 11.32 • n=93 Participants
|
54.5 Years
STANDARD_DEVIATION 11.36 • n=4 Participants
|
54.7 Years
STANDARD_DEVIATION 11.30 • n=27 Participants
|
|
Age, Customized
Age group (years) · <50 years
|
20 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Age, Customized
Age group (years) · >=50 - <65 years
|
33 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Age, Customized
Age group (years) · >=65 -<85 years
|
14 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Age, Customized
Age group (years) · >=85 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
67 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
134 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.Population: Full analysis set
A subject was considered to be a responder if, during the evaluation period, they maintained a pre-dialysis serum potassium (S-K) between 4.0 and 5.0 mmol/L on at least 3 out of 4 dialysis treatments following the long inter-dialytic interval (LIDI) and did not receive rescue therapy. Subjects with no data during the evaluation period were classified as non-responders. The S-K levels used for this analysis were based on the measurements obtained by the central laboratory.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=67 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
Placebo
n=67 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
|---|---|---|
|
Percentage of Responders
|
25 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.Population: Full analysis set
Probability of maintaining maximum S-K value \<= 5.5 mmol/L was evaluated. Each subject's maximum pre-dialysis S-K at long inter-dialytic interval (LIDI) and short inter-dialytic interval (SIDI) visits during the evaluation period were categorised into \<= 5.5 or \> 5.5 mmol/L. Missing S-K values including those omitted due to coinciding with rescue therapy use or records omitted that are not true LIDI (i.e. records which do not occur \>= 55 hours after the previous dialysis starting time) were imputed using multiple imputation (MI).
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=67 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
Placebo
n=67 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
|---|---|---|
|
Maximum Pre-dialysis S-K Values After SIDI and LIDI Below or Equal to 5.5 mmol/L During Evaluation Period
|
0.54 Probability
|
0.15 Probability
|
SECONDARY outcome
Timeframe: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.Population: Full analysis set
Probability of all S-K values between 3.5 and 5.5 mmol/L was evaluated. Subjects were categorised to either having all pre-dialysis LIDI values between 3.5 and 5.5 mmol/L during the evaluation period or not. Missing S-K values including those omitted due to coinciding with rescue therapy use or records omitted that are not true LIDI (i.e. records which do not occur \>= 55 hours after the previous dialysis starting time) were imputed using multiple imputation (MI).
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=67 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
Placebo
n=67 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
|---|---|---|
|
Pre-dialysis S-K After LIDI Between 3.5 and 5.5 mmol/L During the Evaluation Period
|
0.58 Probability
|
0.17 Probability
|
SECONDARY outcome
Timeframe: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.Population: Full analysis set
The probability of maintaining instances of pre-dialysis S-K between 4.0 and 5.0 mmol/L (normokalaemia) was evaluated at each LIDI visit during the evaluation period, by categorisation of pre-dialysis S-K into values between 4.0 and 5.0 mmol/L or not. Values coinciding with rescue therapy or not true LIDI (i.e. records which do not occur \>= 55 hours after the previous dialysis starting time) were excluded.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=63 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
Placebo
n=64 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
|---|---|---|
|
Instances of Pre-dialysis S-K After LIDI Between 4.0 and 5.0 mmol/L During the Evaluation Period
|
0.48 Probability
|
0.17 Probability
|
SECONDARY outcome
Timeframe: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.Population: Full analysis set
The expected number of normokalemic instances is the sum of the probabilities of normokalaemic instance at each visit during the evaluation period. Normokalaemic is defined as S-K between 4.0 and 5.0 mmol/L.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=63 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
Placebo
n=64 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
|---|---|---|
|
Expected Number of Normokalaemic (S-K 4.0-5.0 mmol/L) Instances
|
1.91 Sum of probabilities
|
0.70 Sum of probabilities
|
SECONDARY outcome
Timeframe: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.Population: Full analysis set
The probability of maintaining instances of potassium gradient of \< 3.0 mmol/L was evaluated at each LIDI visit during the evaluation period, by categorisation of potassium gradient into \< 3.0 or \>=3.0 mmol/L. Values coinciding with rescue therapy or not true LIDI (i.e. records which do not occur \>= 55 hours after the previous dialysis starting time) were excluded.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=63 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
Placebo
n=64 Participants
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
|---|---|---|
|
Instances of Potassium Gradient of < 3.0 mmol/L After LIDI During the Evaluation Period
|
0.52 Probability
|
0.16 Probability
|
Adverse Events
Sodium Zirconium Cyclosilicate (SZC)
Serious events: 6 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 25 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=66 participants at risk
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
Placebo
n=67 participants at risk
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/66 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
1.5%
1/67 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.00%
0/66 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
1.5%
1/67 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/66 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
4.5%
3/67 • Number of events 3 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Injury, poisoning and procedural complications
Traumatic renal injury
|
1.5%
1/66 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
0.00%
0/67 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.5%
1/66 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
0.00%
0/67 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Cardiac disorders
Cardiac failure
|
1.5%
1/66 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
0.00%
0/67 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
1.5%
1/66 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
0.00%
0/67 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.00%
0/66 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
1.5%
1/67 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/66 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
1.5%
1/67 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Vascular disorders
Venous stenosis
|
0.00%
0/66 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
1.5%
1/67 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Gastrointestinal disorders
Haemorrhagic gastroenteritis
|
1.5%
1/66 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
0.00%
0/67 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/66 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
1.5%
1/67 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/66 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
1.5%
1/67 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.5%
1/66 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
0.00%
0/67 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
Other adverse events
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=66 participants at risk
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
Placebo
n=67 participants at risk
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose).
Single dose contains 1 to 3 sachets that should be suspended in 45 mL of water by patient and administered on non-dialysis days.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
4/66 • Number of events 5 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
1.5%
1/67 • Number of events 1 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/66 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
4.5%
3/67 • Number of events 3 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.5%
1/66 • Number of events 2 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
4.5%
3/67 • Number of events 3 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.6%
7/66 • Number of events 10 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
9.0%
6/67 • Number of events 7 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
3.0%
2/66 • Number of events 3 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
4.5%
3/67 • Number of events 4 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Nervous system disorders
Dizziness
|
4.5%
3/66 • Number of events 3 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
0.00%
0/67 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Nervous system disorders
Headache
|
4.5%
3/66 • Number of events 3 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
3.0%
2/67 • Number of events 2 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Vascular disorders
Dialysis hypotension
|
4.5%
3/66 • Number of events 17 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
6.0%
4/67 • Number of events 10 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Vascular disorders
Hypotension
|
4.5%
3/66 • Number of events 4 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
4.5%
3/67 • Number of events 4 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/66 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
4.5%
3/67 • Number of events 3 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
6/66 • Number of events 8 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
3.0%
2/67 • Number of events 2 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/66 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
4.5%
3/67 • Number of events 3 • Includes adverse events that occurred from time of randomization throughout the treatment period and follow-up period, up to end of study visit (Day 71 +/- 3 days) or premature study discontinuation visit.
Safety Analysis Set (All randomized subjects who received at least 1 dose of investigational product, SZC or placebo. N=66 for SZC, N=67 for Placebo). Subjects excluded from the Safety Analysis Set (n=1 for SZC, n=0 Placebo) did not receive treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place