Trial · NCT03303521
A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.
NCT03303521, Phase 3, Completed, AstraZeneca; results first posted 2020-02-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients. Trials, record NCT03303521. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03303521
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.
- NCT number
- NCT03303521
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 196 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Hyperkalemia
- Interventions
- Placebo, Sodium Zirconium Cyclosilicate (ZS)
- First posted
- 2017-10-06
- Last updated
- 2020-02-20
- Other registries' IDs
- eudract:2017-003029-14
- Results first posted
- 2020-02-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Responders | Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15. | 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 and did not receive rescue therapy. The S-K levels used for this analysis were based on the measurements obtained by the central laboratory. |
| Primary | Percentage of Responders When Accounting for Missing Central Laboratory Serum Potassium Data | Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15. | The sensitivity analysis assessed the impact of subjects classified as non-responders due to missing serum potassium (S-K) data. Missing central lab (c-lab) pre-dialysis values were imputed using corresponding pre-dialysis i-STAT (a portable blood analyser) measurements. In addition, a "last observation carried forward" (LOCF) approach was utilized to further impute missing values of pre-dialysis S-K during the evaluation period. This technique will replace missing c-lab S-K values with the last available non-missing pre-dialysis LIDI observation recorded for that patient (and this could be a c-lab value or an imputed c-lab value). The Primary endpoint analysis was repeated on the imputed data. |
| Secondary | Percentage of Patients Needing Rescue Therapy | An 8 week overall treatment period (a 4 week adjustment phase plus a 4 week evaluation phase) and a 2 week follow up period. | Patients requiring any urgent intervention consistent with local practice patterns to reduce serum potassium (S-K) including insulin/glucose, beta-adrenergic agonists, sodium bicarbonate, K binders or any form of renal replacement therapy. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Responders | Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15. | Full Analysis Set (all randomized patients) | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Needing Rescue Therapy | An 8 week overall treatment period (a 4 week adjustment phase plus a 4 week evaluation phase) and a 2 week follow up period. | Full Analysis Set (all randomized patients) | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Responders When Accounting for Missing Central Laboratory Serum Potassium Data | Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15. | Full Analysis Set (all randomized patients) | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Responders | Sodium Zirconium Cyclosilicate (SZC) | 41.2 | Percentage of participants | ||
| Percentage of Responders | Placebo | 1.0 | Percentage of participants | ||
| Percentage of Patients Needing Rescue Therapy | Sodium Zirconium Cyclosilicate (SZC) | 2.1 | Percentage of participants | ||
| Percentage of Patients Needing Rescue Therapy | Placebo | 5.1 | Percentage of participants | ||
| Percentage of Responders When Accounting for Missing Central Laboratory Serum Potassium Data | Sodium Zirconium Cyclosilicate (SZC) | 42.3 | Percentage of participants | ||
| Percentage of Responders When Accounting for Missing Central Laboratory Serum Potassium Data | Placebo | 2.0 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sodium Zirconium Cyclosilicate (SZC) | 97 | |
| Overall Study | STARTED | Placebo | 99 | |
| Overall Study | COMPLETED | Sodium Zirconium Cyclosilicate (SZC) | 92 | |
| Overall Study | COMPLETED | Placebo | 96 | |
| Overall Study | NOT COMPLETED | Sodium Zirconium Cyclosilicate (SZC) | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events32
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 | Nasopharyngitis | Infections and infestations | Sodium Zirconium Cyclosilicate (SZC) | 3 | 96 | 4 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 5 | 99 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Sodium Zirconium Cyclosilicate (SZC) | 4 | 96 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 99 | 6 |
| serious | Bacteraemia | Infections and infestations | Sodium Zirconium Cyclosilicate (SZC) | 0 | 96 | 0 |
| serious | Bacteraemia | Infections and infestations | Placebo | 1 | 99 | 1 |
| serious | Gangrene | Infections and infestations | Sodium Zirconium Cyclosilicate (SZC) | 1 | 96 | 1 |
| serious | Gangrene | Infections and infestations | Placebo | 0 | 99 | 0 |
| serious | Gastroenteritis viral | Infections and infestations | Sodium Zirconium Cyclosilicate (SZC) | 1 | 96 | 1 |
| serious | Gastroenteritis viral | Infections and infestations | Placebo | 0 | 99 | 0 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sodium Zirconium Cyclosilicate (SZC) | 1 | 96 |
| Total, all-cause mortality | Placebo | 0 | 99 |
| Total, other adverse events | Sodium Zirconium Cyclosilicate (SZC) | 7 | 96 |
| Total, other adverse events | Placebo | 11 | 99 |
| Total, serious adverse events | Sodium Zirconium Cyclosilicate (SZC) | 7 | 96 |
| Total, serious adverse events | Placebo | 8 | 99 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sodium Zirconium Cyclosilicate (SZC) vs Placebo: deaths from any cause | Trial comparisons |
| Sodium Zirconium Cyclosilicate (SZC) vs Placebo: serious adverse events | Trial comparisons |
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03303521
GET https://conductscience.org/api/trials/v1/NCT03303521/events?page=2