Trial · NCT02088073
Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.
NCT02088073, Phase 3, Completed, ZS Pharma, Inc.; results first posted 2018-12-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia. Trials, record NCT02088073. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02088073
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.
- NCT number
- NCT02088073
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 258 participants, actual
- Lead sponsor
- ZS Pharma, Inc.
- Conditions
- Hyperkalemia
- Interventions
- Sodium zirconium cyclosilicate, Placebo
- First posted
- 2014-03-14
- Last updated
- 2018-12-07
- Results first posted
- 2018-12-07
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). | 22 Days; Maintenance Phase Days 8 - 29, inclusive. | The least squares means (LSMeans) are dervied from a mixed effects model of serial log transformed S-K values between Days 8 and 29 with patients as a random effect and the following fixed effects terms: MP treatment group; AP baseline eGFR; AP and MP baseline S-K levels, age categories (\<55, 55-64, \>= 65 years); and binary indicators for RAAS inhibitors use, CKD, CHF, and DM. The LSmeans estimate obtained from the above model is back-transformed and presented as the lsmeans of all available S-K values during the Maintenance phase study Days 8 to 29. |
| Secondary | The Number of Normokalemic Days Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT). | 22 days; Maintenance Phase Day 8 - 29, inclusive. | The number of normokalemic days during the Maintenance Phase Study Days 8 to 29 is calculated assuming that the interval between assessments is normokalemic only if both the beginning and end assessments for that time interval display normal S-K values (i.e. 3.5 - 5.0 mmol/L) |
| Secondary | Mean Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit . | Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive. | |
| Secondary | Mean Percent Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit, Inclusive . | Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive. | |
| Secondary | Mean Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit. | Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive. | |
| Secondary | Mean Percent Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit. | Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive. | |
| Secondary | Median Time to Hyperkalemia (S-K ≥ 5.1mmol/L) | Maintenance Phase baseline to maintenance Phase Study Day 29/Exit. | |
| Secondary | Mean S-K Intra-subject Standard Deviation Calculated Among Subjects With ≥ 2 Values on or After Maintenance Phase Study Day 8 | 22 days; Maintenance Phase Day 8 - 29 | |
| Secondary | Proportion of Subjects Who Remained Normokalemic During Maintenance Phase | Maintenance Phase Study Days 1, 2, 5, 8, 12, 15, 19, 22, 26, 29, and 35, inclusive. | |
| Secondary | Median Time to Relapse in S-K Values | Maintenance phase Study Day 1 to Study Day 29/Exit. | Median time to relapse in S-K values (return to original Acute Phase S-K baseline value) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). | 22 Days; Maintenance Phase Days 8 - 29, inclusive. | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized patients who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | The Number of Normokalemic Days Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT). | 22 days; Maintenance Phase Day 8 - 29, inclusive. | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized patients who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Days | MEAN |
| SECONDARY | Mean Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit . | Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive. | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | mmol/L | MEAN |
| SECONDARY | Mean Percent Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit, Inclusive . | Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive. | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Percent Change | MEAN |
| SECONDARY | Mean Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit. | Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive. | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | mmol/L | MEAN |
| SECONDARY | Mean Percent Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit. | Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive. | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Percent Change | MEAN |
| SECONDARY | Median Time to Hyperkalemia (S-K ≥ 5.1mmol/L) | Maintenance Phase baseline to maintenance Phase Study Day 29/Exit. | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Days | MEDIAN |
| SECONDARY | Mean S-K Intra-subject Standard Deviation Calculated Among Subjects With ≥ 2 Values on or After Maintenance Phase Study Day 8 | 22 days; Maintenance Phase Day 8 - 29 | Maintenance Phase Intent- to-Treat (ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Day 8. | mmol/L | MEAN |
| SECONDARY | Proportion of Subjects Who Remained Normokalemic During Maintenance Phase | Maintenance Phase Study Days 1, 2, 5, 8, 12, 15, 19, 22, 26, 29, and 35, inclusive. | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Proportion of subjects | NUMBER |
| SECONDARY | Median Time to Relapse in S-K Values | Maintenance phase Study Day 1 to Study Day 29/Exit. | Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8. | Days | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group230
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). | Placebo Comparator (Maintenance Phase) | 5.0603 | 95% Confidence Interval 4.9646 to 5.1578 | mmol/L | |
| Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). | ZS 5 g Once Daily (Maintenance Phase) | 4.7544 | 95% Confidence Interval 4.6350 to 4.8769 | mmol/L | |
| Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). | ZS 10 g Once Daily (Maintenance Phase) | 4.5081 | 95% Confidence Interval 4.4005 to 4.6184 | mmol/L | |
| Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). | ZS 15 g Once Daily (Maintenance Phase) | 4.3742 | 95% Confidence Interval 4.2754 to 4.4753 | mmol/L | |
| The Number of Normokalemic Days Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT). | Placebo Comparator (Maintenance Phase) | 7.4 | Standard Deviation 8.0 | Days | |
| The Number of Normokalemic Days Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT). | ZS 5 g Once Daily (Maintenance Phase) | 13.4 | Standard Deviation 7.57 | Days | |
| The Number of Normokalemic Days Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT). | ZS 10 g Once Daily (Maintenance Phase) | 13.9 | Standard Deviation 7.91 | Days | |
| The Number of Normokalemic Days Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT). | ZS 15 g Once Daily (Maintenance Phase) | 16.8 | Standard Deviation 6.99 | Days | |
| Mean Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit . | Placebo Comparator (Maintenance Phase) | AP Baseline S-K level | 5.55 | Standard Deviation 0.471 | mmol/L |
| Mean Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit . | ZS 5 g Once Daily (Maintenance Phase) | AP Baseline S-K level | 5.53 | Standard Deviation 0.357 | mmol/L |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Acute Phase | STARTED | ZS 10 g Three Times Daily (Acute Phase) | 258 | |
| Acute Phase | STARTED | Placebo Comparator (Maintenance Phase) | 0 | |
| Acute Phase | STARTED | ZS 5 g Once Daily (Maintenance Phase) | 0 | |
| Acute Phase | STARTED | ZS 10 g Once Daily (Maintenance Phase) | 0 | |
| Acute Phase | STARTED | ZS 15 g Once Daily (Maintenance Phase) | 0 | |
| Acute Phase | COMPLETED | ZS 10 g Three Times Daily (Acute Phase) | 251 | |
| Acute Phase | COMPLETED | Placebo Comparator (Maintenance Phase) | 0 | |
| Acute Phase | COMPLETED | ZS 5 g Once Daily (Maintenance Phase) | 0 | |
| Acute Phase | COMPLETED | ZS 10 g Once Daily (Maintenance Phase) | 0 | |
| Acute Phase | COMPLETED | ZS 15 g Once Daily (Maintenance Phase) | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events190
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 | Anemia | Blood and lymphatic system disorders | ZS 10 g TID (Acute Phase) | 0 | 258 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo Comparator (Maintenance Phase) | 0 | 85 | |
| other | Anemia | Blood and lymphatic system disorders | ZS 5 g Once Daily (Maintenance Phase) | 0 | 45 | |
| other | Anemia | Blood and lymphatic system disorders | ZS 10 g Once Daily (Maintenance Phase) | 0 | 51 | |
| other | Anemia | Blood and lymphatic system disorders | ZS 15 g Once Daily (Maintenance Phase) | 3 | 56 | |
| other | Constipation | Gastrointestinal disorders | ZS 10 g TID (Acute Phase) | 2 | 258 | |
| other | Constipation | Gastrointestinal disorders | Placebo Comparator (Maintenance Phase) | 6 | 85 | |
| other | Constipation | Gastrointestinal disorders | ZS 5 g Once Daily (Maintenance Phase) | 0 | 45 | |
| other | Constipation | Gastrointestinal disorders | ZS 10 g Once Daily (Maintenance Phase) | 1 | 51 | |
| other | Constipation | Gastrointestinal disorders | ZS 15 g Once Daily (Maintenance Phase) | 1 | 56 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZS 10 g TID (Acute Phase) | ||
| Total, all-cause mortality | Placebo Comparator (Maintenance Phase) | ||
| Total, all-cause mortality | ZS 5 g Once Daily (Maintenance Phase) | ||
| Total, all-cause mortality | ZS 10 g Once Daily (Maintenance Phase) | ||
| Total, all-cause mortality | ZS 15 g Once Daily (Maintenance Phase) | ||
| Total, other adverse events | ZS 10 g TID (Acute Phase) | 9 | 258 |
| Total, other adverse events | Placebo Comparator (Maintenance Phase) | 25 | 85 |
| Total, other adverse events | ZS 5 g Once Daily (Maintenance Phase) | 20 | 45 |
| Total, other adverse events | ZS 10 g Once Daily (Maintenance Phase) | 15 | 51 |
| Total, other adverse events | ZS 15 g Once Daily (Maintenance Phase) | 25 | 56 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
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 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
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/NCT02088073
GET https://conductscience.org/api/trials/v1/NCT02088073/results?page=2