A Phase 3 interventional study of Sodium Zirconium Cyclosilicate 5g and Sodium Zirconium Cyclosilicate 10g in Hyperkalemia, sponsored by AstraZeneca. Completed at 66 sites in 2 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having achieved normokalemia following 24 or 48 hours of initial ZS therapy (10g TID).
This study will be conducted in approximately 35 centers in China. Before patients are randomized to the double-blind phase, they will receive open-label ZS for 24 or 48 hours during the initial phase. It is expected that approximately 490 patients will need to be enrolled, to have approximately 280 patients entered into the open-label initial phase resulting in 250 patients being randomized in the 28-day treatment study phase. Enrolment will be stopped when 250 patients have been initiated with the 28-day randomized treatment study phase.
133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.
This study's enrollment of 270 is above the median of 87 across 102 interventional studies indexed under Hyperkalemia.
Browse Hyperkalemia studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Suspension administered 10g orally once daily for 28 days after the open label initial phase.
Drug: Sodium Zirconium Cyclosilicate 10g
Suspension administered 5g orally once daily for 28 days after the open label initial phase.
Drug: Sodium Zirconium Cyclosilicate 5g
Suspension administered orally placebo once daily for 28 days after the open label initial phase.
Drug: Placebo
Suspension administered Sodium Zirconium Cyclosilicate 5g orally once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.
Suspension administered Sodium Zirconium Cyclosilicate 10g orally once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.
Suspension administered orally placebo once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.
Least Square Mean S-K Level on Days 8-29
Comparison between placebo and each SZC treatment group (high to low) with regard to the mean S-K level during the randomized treatment phase days 8-29. Mixed-effects models were used to estimate least-squares means.
Time frame: Days 8 to 29 (Randomized treatment study phase) used for model-based least squares mean computation
Percentage of Patients Who Achieve Normokalemia
Percentage of patients who achieve normokalemia during the open label initial phase at 24 hours and at the end of the open label phase. End of OLP is defined as Day 2 (24 hours post first dose) or Day 3 (48 hours post first dose) depending on when the subject achieved normokalemia based on the pre-dose i-STAT potassium level. The results in the table below are presented for OLP.
Time frame: Through open label initial phase
Exponential Rate of Change in S-K Levels
Exponential rate of change in S-K levels (blood) during the open-label initial phase 24 hours post-dose. Least Square Mean corresponds to the exponential rate of change i.e. the slope (for time) in terms of log-transformed S-K levels. The results in the table below are presented for OLP.
Time frame: Through 24 hours post-dose in the initial phase
Absolute Change From Baseline in S-K Levels
Absolute change from baseline in S-K levels at all measured time intervals. End of OLP is defined as Day 2 (24 hours post first dose) or Day 3 (48 hours post first dose) depending on when the subject achieved normokalemia based on the pre-dose i-STAT potassium level. The results in the table below are presented for OLP.
Time frame: Through open label initial phase
Percentage Change From Baseline in S-K Levels
Percentage change from baseline in S-K levels at all measured time intervals. End of OLP is defined as Day 2 (24 hours post first dose) or Day 3 (48 hours post first dose) depending on when the subject achieved normokalemia based on the pre-dose i-STAT potassium level. The results in the table below are presented for OLP.
Time frame: Through open label initial phase
Proportion of Patients Who Remain Normokalemic During RTP
Proportion of patients who remain normokalemic (as defined by S-K between 3.5-5.0 mmol/l, inclusive) during RTP (Day 8 to Day 29). The results in the table below are presented for RTP.
Time frame: Through 28-day randomized treatment study phase day 8-29
Proportion of Normokalemic Patients at the End of RTP
Proportion of normokalemic patients (as defined by S-K between 3.5-5.0 mmol/l, inclusive). The results in the table below are presented for RTP.
Time frame: The end of 28-day randomized treatment study phase
Days Patients Remain Normokalemic
The number of days patients remain normokalemic during days 8-29 of the randomized treatment study phase. The results in the table below are presented for RTP.
Time frame: Through days 8-29 of the randomized treatment phase.
Mean Change in S-K Levels
The mean change in S-K levels evaluated relative to the RTP baseline. The results in the table below are presented for RTP.
Time frame: Through 28-day randomized treatment phase.
Mean Percent Change in S-K Levels
The mean percent change in S-K levels evaluated relative to the RTP baseline. The results in the table below are presented for RTP.
Time frame: Through 28-day randomized treatment phase.
Least Square Mean Changes in S-Aldo and P-Renin Levels
Comparison between placebo and each SZC treatment group (high to low) with regard to the mean S-Aldo and P-Renin levels during the randomized treatment phase days 15-29.
Time frame: Through 28 day randomized treatment study phase day 15-29
Hyperkalaemia at Day 29
The number of patients with hyperkalaemia at day 29. The results in the table below are presented for RTP.
Time frame: Day 29
Percentage of Patients Without Hyperkalemia
Kaplan-Meier estimate at Day 29 of percentage of patients without hyperkalemia. The results in the table below are presented for RTP.
Time frame: Day 29 of randomized treatment phase
The study was conducted in 35 sites in China.
| Milestone | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Started | 270 | 0 | 0 | 0 |
| Completed | 256 | 0 | 0 | 0 |
| Not completed | 14 | 0 | 0 | 0 |
| Withdrew: Physician decision | 2 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 8 | 0 | 0 | 0 |
| Withdrew: (not collected) | 4 | 0 | 0 | 0 |
| Milestone | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Started | 0 | 100 | 100 | 50 |
| Completed | 0 | 81 | 85 | 38 |
| Not completed | 0 | 19 | 15 | 12 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 |
| Withdrew: Physician decision | 0 | 5 | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 7 | 4 | 1 |
| Withdrew: (study specific withdrawal criteria) | 0 | 3 | 3 | 4 |
| Withdrew: (not collected) | 0 | 4 | 6 | 5 |
Comparison between placebo and each SZC treatment group (high to low) with regard to the mean S-K level during the randomized treatment phase days 8-29. Mixed-effects models were used to estimate least-squares means.
| mmol/L | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Least Square Mean S-K Level on Days 8-29 | — | 4.859 (4.709 to 5.014) | 4.440 (4.304 to 4.580) | 5.225 (5.055 to 5.400) |
Percentage of patients who achieve normokalemia during the open label initial phase at 24 hours and at the end of the open label phase. End of OLP is defined as Day 2 (24 hours post first dose) or Day 3 (48 hours post first dose) depending on when the subject achieved normokalemia based on the pre-dose i-STAT potassium level. The results in the table below are presented for OLP.
| Participants | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Normokalemic at 24h | 180 | — | — | — |
| Normokalemic at End of OLP | 228 | — | — | — |
Exponential rate of change in S-K levels (blood) during the open-label initial phase 24 hours post-dose. Least Square Mean corresponds to the exponential rate of change i.e. the slope (for time) in terms of log-transformed S-K levels. The results in the table below are presented for OLP.
| log(mmol/L)/h | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Exponential Rate of Change in S-K Levels | -0.0051 ± 0.00027 | — | — | — |
Absolute change from baseline in S-K levels at all measured time intervals. End of OLP is defined as Day 2 (24 hours post first dose) or Day 3 (48 hours post first dose) depending on when the subject achieved normokalemia based on the pre-dose i-STAT potassium level. The results in the table below are presented for OLP.
| mmol/L | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| OLP - 24 hours | -0.936 ± 0.377 | — | — | — |
| End of OLP | -1.107 ± 0.466 | — | — | — |
Percentage change from baseline in S-K levels at all measured time intervals. End of OLP is defined as Day 2 (24 hours post first dose) or Day 3 (48 hours post first dose) depending on when the subject achieved normokalemia based on the pre-dose i-STAT potassium level. The results in the table below are presented for OLP.
| Percentage | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| OLP - 24 hours | -15.880 ± 5.980 | — | — | — |
| End of OLP | -18.588 ± 6.701 | — | — | — |
Proportion of patients who remain normokalemic (as defined by S-K between 3.5-5.0 mmol/l, inclusive) during RTP (Day 8 to Day 29). The results in the table below are presented for RTP.
| Average probability | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Proportion of Patients Who Remain Normokalemic During RTP | — | 0.596 | 0.818 | 0.279 |
Proportion of normokalemic patients (as defined by S-K between 3.5-5.0 mmol/l, inclusive). The results in the table below are presented for RTP.
| Participants | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Proportion of Normokalemic Patients at the End of RTP | — | 47 | 65 | 14 |
The number of days patients remain normokalemic during days 8-29 of the randomized treatment study phase. The results in the table below are presented for RTP.
| Day | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Days Patients Remain Normokalemic | — | 9.11 ± 1.413 | 14.54 ± 1.397 | 3.40 ± 1.473 |
The mean change in S-K levels evaluated relative to the RTP baseline. The results in the table below are presented for RTP.
| mmol/L | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Day 2 change from RTP baseline | — | -0.04 ± 0.299 | -0.15 ± 0.314 | 0.02 ± 0.315 |
| Day 5 change from RTP baseline | — | 0.09 ± 0.434 | -0.27 ± 0.464 | 0.40 ± 0.423 |
| Day 8 change from RTP baseline | — | 0.20 ± 0.481 | -0.29 ± 0.541 | 0.53 ± 0.485 |
| Day 12 change from RTP baseline | — | 0.25 ± 0.539 | -0.23 ± 0.597 | 0.67 ± 0.452 |
| Day 15 change from RTP baseline | — | 0.26 ± 0.557 | -0.24 ± 0.581 | 0.67 ± 0.494 |
| Day 19 change from RTP baseline | — | 0.41 ± 0.606 | -0.19 ± 0.616 | 0.61 ± 0.506 |
| Day 22 change from RTP baseline | — | 0.32 ± 0.543 | -0.13 ± 0.538 | 0.62 ± 0.536 |
| Day 26 change from RTP baseline | — | 0.22 ± 0.556 | -0.05 ± 0.627 | 0.55 ± 0.447 |
| Day 29 change from RTP baseline | — | 0.23 ± 0.494 | 0.01 ± 0.578 | 0.47 ± 0.520 |
| EOS change from RTP baseline | — | 0.57 ± 0.499 | 0.67 ± 0.688 | 0.55 ± 0.667 |
The mean percent change in S-K levels evaluated relative to the RTP baseline. The results in the table below are presented for RTP.
| Percent change | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Day 2 change from RTP baseline | — | -0.81 ± 6.308 | -3.13 ± 6.627 | 0.41 ± 6.670 |
| Day 5 change from RTP baseline | — | 2.10 ± 9.009 | -5.57 ± 9.688 | 8.56 ± 8.989 |
| Day 8 change from RTP baseline | — | 4.45 ± 10.260 | -6.05 ± 11.352 | 11.24 ± 9.989 |
| Day 12 change from RTP baseline | — | 5.55 ± 11.564 | -4.65 ± 12.604 | 14.39 ± 9.908 |
| Day 15 change from RTP baseline | — | 5.85 ± 11.840 | -4.85 ± 12.107 | 14.50 ± 10.775 |
| Day 19 change from RTP baseline | — | 9.01 ± 13.285 | -3.76 ± 12.797 | 13.34 ± 11.266 |
| Day 22 change from RTP baseline | — | 7.09 ± 11.952 | -2.59 ± 11.292 | 13.15 ± 11.686 |
| Day 26 change from RTP baseline | — | 5.12 ± 12.130 | -0.76 ± 13.278 | 11.95 ± 9.809 |
| Day 29 change from RTP baseline | — | 5.24 ± 10.941 | 0.48 ± 12.142 | 10.20 ± 11.438 |
| EOS change from RTP baseline | — | 12.42 ± 11.054 | 14.47 ± 14.797 | 11.74 ± 14.477 |
Comparison between placebo and each SZC treatment group (high to low) with regard to the mean S-Aldo and P-Renin levels during the randomized treatment phase days 15-29.
| pmol/L | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| S-Aldo | — | -21.926 (-80.492 to 36.640) | -53.945 (-112.189 to 4.300) | 83.322 (22.519 to 144.124) |
| P-Renin | — | -0.348 (-0.484 to -0.212) | -0.424 (-0.559 to -0.288) | -0.362 (-0.505 to -0.218) |
The number of patients with hyperkalaemia at day 29. The results in the table below are presented for RTP.
| Participants | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Hyperkalaemia at Day 29 | — | 77 | 50 | 48 |
Kaplan-Meier estimate at Day 29 of percentage of patients without hyperkalemia. The results in the table below are presented for RTP.
| Percentage | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Percentage of Patients Without Hyperkalemia | — | 20.3 (12.8 to 29.0) | 47.1 (36.5 to 57.0) | 4.0 (0.7 to 12.1) |
Collected over Adverse Events were collected from the time of the main study informed consent (Day 1, Visit 3) throughout the treatment period and including the End of Study (EOS) visit. Serious Adverse Events were collected from the time of the optional Pre-screening informed consent (Visit 1) throughout the treatment period and including the EOS visit. Maximum duration of treatment was 8 days for open-label initial phase and 30 days for the randomized treatment phase.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sodium Zirconium Cyclosilicate (SZC) 10g TID | 0/270 (0%) | 1/270 (0.4%) | 38/270 (14.1%) |
| Sodium Zirconium Cyclosilicate (SZC) 5g QD | 0/100 (0%) | 6/100 (6%) | 48/100 (48%) |
| Sodium Zirconium Cyclosilicate (SZC) 10g QD | 0/100 (0%) | 3/100 (3%) | 42/100 (42%) |
| Placebo | 0/50 (0%) | 1/50 (2%) | 17/50 (34%) |
| Event | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Abdominal pain upperGastrointestinal disorders | 0/270 | 0/100 | 0/100 | 1/50 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 0/270 | 1/100 | 0/100 | 0/50 |
| OedemaGeneral disorders | 0/270 | 0/100 | 1/100 | 0/50 |
| Oedema peripheralGeneral disorders | 0/270 | 1/100 | 0/100 | 0/50 |
| HyperkalaemiaMetabolism and nutrition disorders | 1/270 | 1/100 | 1/100 | 0/50 |
| Chronic kidney diseaseRenal and urinary disorders | 0/270 | 1/100 | 0/100 | 0/50 |
| End stage renal diseaseRenal and urinary disorders | 0/270 | 1/100 | 1/100 | 0/50 |
| Sleep apnoea syndromeRespiratory, thoracic and mediastinal disorders | 0/270 | 1/100 | 0/100 | 0/50 |
| Event | Sodium Zirconium Cyclosilicate (SZC) 10g TID | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo |
|---|---|---|---|---|
| Oedema peripheralGeneral disorders | 0/270 | 8/100 | 12/100 | 0/50 |
| HyperkalaemiaMetabolism and nutrition disorders | 0/270 | 1/100 | 1/100 | 5/50 |
| ConstipationGastrointestinal disorders | 3/270 | 7/100 | 5/100 | 0/50 |
| Upper respiratory tract infectionInfections and infestations | 2/270 | 4/100 | 4/100 | 0/50 |
| DizzinessNervous system disorders | 3/270 | 4/100 | 3/100 | 2/50 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/270 | 0/100 | 2/100 | 2/50 |
| Eyelid oedemaEye disorders | 1/270 | 0/100 | 3/100 | 0/50 |
| DiarrhoeaGastrointestinal disorders | 4/270 | 0/100 | 3/100 | 1/50 |
| VomitingGastrointestinal disorders | 3/270 | 1/100 | 3/100 | 0/50 |
| Peripheral swellingGeneral disorders | 0/270 | 0/100 | 3/100 | 0/50 |
The study consisted of two phases, an Open-label initial phase (OLP) and a Randomized treatment phase (RTP). 270 participants entered OLP, out of these 250 entered RTP \& received Placebo, SZC 5g QD or SZC 10g QD in a 1:2:2 ratio.
| Age, Continuous(Years) | Sodium Zirconium Cyclosilicate (SZC) | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo | Total |
|---|---|---|---|---|---|
| Randomized treatment phase (RTP) | — | 54.3 ± 13.92 | 55.6 ± 14.47 | 59.7 ± 14.2 | 55.9 ± 14.28 |
| Open-label initial phase (OLP) | 56.4 ± 14.17 | — | — | — | 56.4 ± 14.17 |
| Sex: Female, Male(Participants) | Sodium Zirconium Cyclosilicate (SZC) | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo | Total |
|---|---|---|---|---|---|
| Randomized treatment phase (RTP) — Female | — | 35 | 40 | 19 | 94 |
| Randomized treatment phase (RTP) — Male | — | 65 | 60 | 31 | 156 |
| Open-label initial phase (OLP) — Female | 103 | — | — | — | 103 |
| Open-label initial phase (OLP) — Male | 167 | — | — | — | 167 |
| Race/Ethnicity, Customized(Participants) | Sodium Zirconium Cyclosilicate (SZC) | Sodium Zirconium Cyclosilicate (SZC) 5g QD | Sodium Zirconium Cyclosilicate (SZC) 10g QD | Placebo | Total |
|---|---|---|---|---|---|
| Not Hispanic or Latino Randomized treatment phase (RTP) | — | 100 | 100 | 50 | 250 |
| Not Hispanic or Latino Open-label initial phase (OLP) | 270 | — | — | — | 270 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
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Studies of the drug tested here: Sodium zirconium cyclosilicate