Trial · NCT03172702
Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia
NCT03172702, Phase 3, Completed, AstraZeneca; results first posted 2020-05-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia. Trials, record NCT03172702. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03172702
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia
- NCT number
- NCT03172702
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Hyperkalemia
- Interventions
- Zirconium Cyclosilicate
- First posted
- 2017-06-01
- Last updated
- 2020-05-01
- Results first posted
- 2020-05-01
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Experienced Adverse Events (AEs) in the MP | First MP dose up to 1 day (2 days for QOD regimen) after last MP dose. | The number of patients who experienced any AE, including those which were serious (SAE), had an outcome of death, were severe, led to discontinuation of ZS or were causally related to ZS are presented for the MP. AEs of special interest are also presented, including oedema-related AEs, cardiac failure and hypertension. |
| Secondary | Percentage of Patients Who Were Normokalemic in the MP | MP Day 1 to End of Study visit (up to 12 months). | The percentage of patients who were normokalemic at each study visit in the MP is presented. Normokalemia was defined as a serum potassium (S-K) level of ≥ 3.5 and ≤ 5.0 mmol/L. The percentage of patients who were normokalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days. |
| Secondary | Percentage of Patients With Average S-K Levels of ≤5.1 mmol/L and ≤5.5 mmol/L in the MP | MP Day 2 to Day 362. | The percentage of patients who had an average S-K level of ≤5.1 mmol/L and ≤5.5 mmol/L over the MP up to Day 362 is presented. |
| Secondary | Percentage of Patients Who Were Hypokalemic in the MP | MP Day 1 to End of Study visit (up to 12 months). | The percentage of patients who were hypokalemic at each study visit in the MP is presented. Hypokalemia was defined as a S-K level of \< 3.5 mmol/L. The percentage of patients who were hypokalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days. |
| Secondary | Percentage of Patients Who Were Hyperkalemic in the MP | MP Day 1 to End of Study visit (up to 12 months). | The percentage of patients who were hyperkalemic at each study visit in the MP is presented. Hyperkalemia was defined as a S-K level of \>5.0 mmol/L. The percentage of patients who were hyperkalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days. |
| Secondary | Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP | CP Day 1 to MP Day 362. | The mean changes from the CP baseline in S-K level over specified periods of time in the MP are presented. Baseline for the CP was defined as the mean of 2 different S-K values, recorded 60 minutes apart (to confirm qualification for study entry) on the CP Day 1. |
| Secondary | Mean Change From MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP | MP Day 1 to Day 362. | The mean changes from the MP baseline in S-K level over specified periods of time in the MP are presented. Baseline for the MP was defined as the measurement taken in the morning of the day of entering the MP (MP Day 1). |
| Secondary | Mean Number of Normokalemic Days During the MP | MP Day 1 to Day 362. | The number of normokalemic days during the MP was calculated assuming the time interval between assessments was normokalemic if both the beginning and end assessments for that time interval displayed normal S-K values. If an intermediate scheduled assessment time point was missing, then the scheduled assessment was regarded as not normokalemic. The mean number of normokalemic days for a patient in the MP is presented. |
| Secondary | Mean Change in S-K Level From Last On-treatment MP Visit to the End of Study | MP Day 1 to End of Study visit (up to 12 months). | The mean change in the S-K level from the last on-treatment MP visit to the End of Study is presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose. |
| Secondary | Change From CP Baseline in S-Aldosterone Levels Over the MP | CP Day 1, MP Day 166 and MP Day 362. | The mean change from CP baseline to MP Day 166 and MP Day 362 in S-aldosterone levels is presented. In addition, the mean change from CP baseline to the last on-treatment value is presented. The CP baseline was defined as the last S-aldosterone assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who Experienced Adverse Events (AEs) in the MP | First MP dose up to 1 day (2 days for QOD regimen) after last MP dose. | The safety analysis set for the MP (SAF-MP) included all patients treated with at least 1 dose of MP ZS and who had any MP safety data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Who Were Normokalemic in the MP | MP Day 1 to End of Study visit (up to 12 months). | The full analysis set for the MP (FAS-MP) included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With Average S-K Levels of ≤5.1 mmol/L and ≤5.5 mmol/L in the MP | MP Day 2 to Day 362. | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Were Hypokalemic in the MP | MP Day 1 to End of Study visit (up to 12 months). | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Were Hyperkalemic in the MP | MP Day 1 to End of Study visit (up to 12 months). | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Percentage of patients | NUMBER |
| SECONDARY | Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP | CP Day 1 to MP Day 362. | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | mmol/L | MEAN |
| SECONDARY | Mean Change From MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP | MP Day 1 to Day 362. | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | mmol/L | MEAN |
| SECONDARY | Mean Number of Normokalemic Days During the MP | MP Day 1 to Day 362. | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Days | MEAN |
| SECONDARY | Mean Change in S-K Level From Last On-treatment MP Visit to the End of Study | MP Day 1 to End of Study visit (up to 12 months). | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | mmol/L | MEAN |
| SECONDARY | Change From CP Baseline in S-Aldosterone Levels Over the MP | CP Day 1, MP Day 166 and MP Day 362. | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Picomole per liter (pmol/L) | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Who Experienced Adverse Events (AEs) in the MP | Sodium Zirconium Cyclosilicate | Any AE | 131 | Participants | |
| Number of Patients Who Experienced Adverse Events (AEs) in the MP | Sodium Zirconium Cyclosilicate | Any AE with outcome death | 2 | Participants | |
| Number of Patients Who Experienced Adverse Events (AEs) in the MP | Sodium Zirconium Cyclosilicate | Any SAE | 27 | Participants | |
| Number of Patients Who Experienced Adverse Events (AEs) in the MP | Sodium Zirconium Cyclosilicate | Any severe AE | 9 | Participants | |
| Number of Patients Who Experienced Adverse Events (AEs) in the MP | Sodium Zirconium Cyclosilicate | Any AE leading to ZS discontinuation | 12 | Participants | |
| Number of Patients Who Experienced Adverse Events (AEs) in the MP | Sodium Zirconium Cyclosilicate | Any causally related AE | 30 | Participants | |
| Number of Patients Who Experienced Adverse Events (AEs) in the MP | Sodium Zirconium Cyclosilicate | Oedema-related AE | 31 | Participants | |
| Number of Patients Who Experienced Adverse Events (AEs) in the MP | Sodium Zirconium Cyclosilicate | Cardiac failure | 10 | Participants | |
| Number of Patients Who Experienced Adverse Events (AEs) in the MP | Sodium Zirconium Cyclosilicate | Hypertension | 24 | Participants | |
| Percentage of Patients Who Were Normokalemic in the MP | Sodium Zirconium Cyclosilicate | MP Day 1 | 82.0 | 95% Confidence Interval 74.9 to 87.8 | Percentage of patients |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sodium Zirconium Cyclosilicate | 150 | |
| Overall Study | Received Treatment in CP | Sodium Zirconium Cyclosilicate | 150 | |
| Overall Study | Received Treatment in MP | Sodium Zirconium Cyclosilicate | 150 | |
| Overall Study | COMPLETED | Sodium Zirconium Cyclosilicate | 122 | |
| Overall Study | NOT COMPLETED | Sodium Zirconium Cyclosilicate | 28 |
Source ClinicalTrials.gov
Adverse events60
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 | Correction Phase | 0 | 150 | |
| other | Oedema peripheral | General disorders | Maintenance Phase | 23 | 150 | |
| other | Nasopharyngitis | Infections and infestations | Correction Phase | 1 | 150 | |
| other | Nasopharyngitis | Infections and infestations | Maintenance Phase | 36 | 150 | |
| other | Hypertension | Vascular disorders | Correction Phase | 0 | 150 | |
| other | Hypertension | Vascular disorders | Maintenance Phase | 23 | 150 | |
| other | Constipation | Gastrointestinal disorders | Correction Phase | 0 | 150 | |
| other | Constipation | Gastrointestinal disorders | Maintenance Phase | 20 | 150 | |
| serious | Diabetes mellitus | Metabolism and nutrition disorders | Correction Phase | 1 | 150 | |
| serious | Diabetes mellitus | Metabolism and nutrition disorders | Maintenance Phase | 0 | 150 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Correction Phase | 0 | 150 |
| Total, all-cause mortality | Maintenance Phase | 2 | 150 |
| Total, other adverse events | Correction Phase | 1 | 150 |
| Total, other adverse events | Maintenance Phase | 79 | 150 |
| Total, serious adverse events | Correction Phase | 1 | 150 |
| Total, serious adverse events | Maintenance Phase | 27 | 150 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33098526 | DERIVED |
Source PubMed
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 |
|---|---|
| Correction Phase vs Maintenance Phase: deaths from any cause | Trial comparisons |
| Correction Phase vs Maintenance Phase: 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.
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GET https://conductscience.org/api/trials/v1/NCT03172702/results?page=2