Trial · NCT02875834
A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia
NCT02875834, Phase 3, Completed, AstraZeneca; results first posted 2020-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia. Trials, record NCT02875834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02875834
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia
- NCT number
- NCT02875834
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 267 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Hyperkalemia
- Interventions
- Sodium Zirconium Cyclosilicate (ZS) 10g, Sodium Zirconium Cyclosilicate (ZS) 5g, Sodium Zirconium Cyclosilicate (ZS) 10g, Placebo
- First posted
- 2016-08-23
- Last updated
- 2020-08-19
- Results first posted
- 2020-08-19
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Least Square Mean S-K Level on Days 8-29 | Through 28-day randomized treatment study phase day 8-29. | Comparison between placebo and the active ZS treatment groups (each dose group will be sequentially compared with placebo, starting with the highest and ending with the lowest dose) with regard to the mean S-K level during the 28-day randomized treatment study phase Days 8-29. The results in the table below are presented for RTP. |
| Secondary | Proportion of Patients Achieving Normokalemia | Through 48-hour initial phase. | Proportion of patients who achieve normokalemia during the initial phase at 24 and 48 hours. The results in the table below are presented for OLP. (h=hours). |
| Secondary | Exponential Rate of Change in S-K Levels | Through 48-hour initial phase. | Exponential rate of change in S-K levels (blood) during the 48-hour open-label initial phase. The results in the table below are presented for OLP. |
| Secondary | Absolute Change From Baseline in S-K Levels | Through 48-hour initial phase. | Absolute change from baseline in S-K levels at all measured time intervals. The results in the table below are presented for OLP. |
| Secondary | Percentage Change From Baseline in S-K Levels | Through 48-hour initial phase. | Percentage change from baseline in S-K levels at all measured time intervals. The results in the table below are presented for OLP. |
| Secondary | Proportion of Patients Remaining Normokalemic | Through 28-day randomized treatment study phase day 8-29. | The proportion of patients who remain normokalemic (as defined by S-K between 3.5-5.0 mmol/l, inclusive) at the end of the 28-day randomized treatment study phase and during the 28-day randomized treatment study phase. The results in the table below are presented for RTP. |
| Secondary | Proportion of Normokalemic Patients at Day 1 Through Day 29/Exit | Through 28-day randomized treatment phase. | The proportion of patients who are normokalemic (as defined by S-K between 3.5-5.0 mmol/l, inclusive) at Day 1 through Day 29/Exit in randomization phase. The results in the table below are presented for RTP. |
| Secondary | Days Patients Remain Normokalemic | Through 28-day randomized treatment phase. | The number of days patients remain normokalemic during the 28-day randomized treatment study phase. The results in the table below are presented for RTP. |
| Secondary | Mean Change in S-K Levels | Through 28-day randomized treatment phase. | The mean change in S-K levels evaluated relative to both baselines. The results in the table below are presented for RTP. |
| Secondary | Mean Percentage Change in S-K Levels | Through 28-day randomized treatment phase. | The mean percentage change in S-K levels evaluated relative to both baselines. The results in the table below are presented for RTP. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Least Square Mean S-K Level on Days 8-29 | Through 28-day randomized treatment study phase day 8-29. | Full Analysis Set | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Patients Achieving Normokalemia | Through 48-hour initial phase. | Full Analysis Set | Participants | NUMBER |
| SECONDARY | Exponential Rate of Change in S-K Levels | Through 48-hour initial phase. | Full Analysis Set | log(mmol/L)/h | MEAN |
| SECONDARY | Absolute Change From Baseline in S-K Levels | Through 48-hour initial phase. | Full Analysis Set | mmol/L | MEAN |
| SECONDARY | Percentage Change From Baseline in S-K Levels | Through 48-hour initial phase. | Full Analysis Set | Percentage change | MEAN |
| SECONDARY | Proportion of Patients Remaining Normokalemic | Through 28-day randomized treatment study phase day 8-29. | Full Analysis Set | Participants | NUMBER |
| SECONDARY | Proportion of Normokalemic Patients at Day 1 Through Day 29/Exit | Through 28-day randomized treatment phase. | Full Analysis Set | Participants | NUMBER |
| SECONDARY | Days Patients Remain Normokalemic | Through 28-day randomized treatment phase. | Full Analysis Set | Day | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in S-K Levels | Through 28-day randomized treatment phase. | Full Analysis Set | mmol/L | MEAN |
| SECONDARY | Mean Percentage Change in S-K Levels | Through 28-day randomized treatment phase. | Full Analysis Set | Percentage change | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group208
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Least Square Mean S-K Level on Days 8-29 | Sodium Zirconium Cyclosilicate (ZS) 5g | 4.811 | 95% Confidence Interval 4.685 to 4.940 | mmol/L | |
| Least Square Mean S-K Level on Days 8-29 | Sodium Zirconium Cyclosilicate (ZS) 10g | 4.381 | 95% Confidence Interval 4.265 to 4.501 | mmol/L | |
| Least Square Mean S-K Level on Days 8-29 | Placebo | 5.321 | 95% Confidence Interval 5.155 to 5.493 | mmol/L | |
| Proportion of Patients Achieving Normokalemia | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | Normokalemic at 24h | 169 | Participants | |
| Proportion of Patients Achieving Normokalemia | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | Not Normokalemic at 24h | 93 | Participants | |
| Proportion of Patients Achieving Normokalemia | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | Missing at 24h | 5 | Participants | |
| Proportion of Patients Achieving Normokalemia | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | Normokalemic at 48h | 238 | Participants | |
| Proportion of Patients Achieving Normokalemia | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | Not Normokalemic at 48h | 22 | Participants | |
| Proportion of Patients Achieving Normokalemia | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | Missing at 48h | 7 | Participants | |
| Exponential Rate of Change in S-K Levels | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | -0.004 | Standard Error 0.0001 | log(mmol/L)/h |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Phase | STARTED | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | 267 | |
| Open-label Phase | STARTED | Sodium Zirconium Cyclosilicate (ZS) 5g | 0 | |
| Open-label Phase | STARTED | Sodium Zirconium Cyclosilicate (ZS) 10g | 0 | |
| Open-label Phase | STARTED | Placebo | 0 | |
| Open-label Phase | COMPLETED | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | 260 | |
| Open-label Phase | COMPLETED | Sodium Zirconium Cyclosilicate (ZS) 5g | 0 | |
| Open-label Phase | COMPLETED | Sodium Zirconium Cyclosilicate (ZS) 10g | 0 | |
| Open-label Phase | COMPLETED | Placebo | 0 | |
| Open-label Phase | NOT COMPLETED | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | 7 | |
| Open-label Phase | NOT COMPLETED | Sodium Zirconium Cyclosilicate (ZS) 5g | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oedema peripheral | General disorders | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | 0 | 267 | 0 |
| other | Oedema peripheral | General disorders | Sodium Zirconium Cyclosilicate (ZS) 5g | 4 | 99 | 4 |
| other | Oedema peripheral | General disorders | Sodium Zirconium Cyclosilicate (ZS) 10g | 7 | 99 | 7 |
| other | Oedema peripheral | General disorders | Placebo | 0 | 50 | 0 |
| other | Constipation | Gastrointestinal disorders | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | 0 | 267 | 0 |
| other | Constipation | Gastrointestinal disorders | Sodium Zirconium Cyclosilicate (ZS) 5g | 1 | 99 | 1 |
| other | Constipation | Gastrointestinal disorders | Sodium Zirconium Cyclosilicate (ZS) 10g | 9 | 99 | 9 |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 50 | 0 |
| other | Oedema | General disorders | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | 0 | 267 | 0 |
| other | Oedema | General disorders | Sodium Zirconium Cyclosilicate (ZS) 5g | 1 | 99 | 1 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | 0 | 267 |
| Total, all-cause mortality | Sodium Zirconium Cyclosilicate (ZS) 5g | 0 | 99 |
| Total, all-cause mortality | Sodium Zirconium Cyclosilicate (ZS) 10g | 0 | 99 |
| Total, all-cause mortality | Placebo | 0 | 50 |
| Total, other adverse events | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | 0 | 267 |
| Total, other adverse events | Sodium Zirconium Cyclosilicate (ZS) 5g | 6 | 99 |
| Total, other adverse events | Sodium Zirconium Cyclosilicate (ZS) 10g | 21 | 99 |
| Total, other adverse events | Placebo | 0 | 50 |
| Total, serious adverse events | Sodium Zirconium Cyclosilicate (ZS) 10g Tid | 0 | 267 |
| Total, serious adverse events | Sodium Zirconium Cyclosilicate (ZS) 5g | 4 | 99 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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