Trial · NCT01737697
Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia
NCT01737697, Phase 3, Completed, ZS Pharma, Inc.; results first posted 2018-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia. Trials, record NCT01737697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01737697
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia
- NCT number
- NCT01737697
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 754 participants, actual
- Lead sponsor
- ZS Pharma, Inc.
- Conditions
- Hyperkalemia
- Interventions
- Zirconium silicate (acute phase), Zirconium silicate (subacute phase), Placebo (acute phase), Placebo ( subacute phase)
- First posted
- 2012-11-29
- Last updated
- 2018-10-12
- Results first posted
- 2018-10-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Through 48 hours acute phase | |
| Primary | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through 12 days subacute phase (Day 3 through Day 15) | |
| Secondary | Percentage of Subjects Who Achieve Normalization in S-K Levels After 48 Hours of Treatment | Through 48 hours acute phase | |
| Secondary | Mean Change From Baseline in S-K at All Time Points Acute Phase | Through 48 hours acute phase. In particular, at Baseline; 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3. | Mean change from baseline in S-K at all time points over initial 48 hours |
| Secondary | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Through 48 hours acute phase. In particular, 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3. | Mean percent change from baseline in S-K at all time points over initial 48 hours |
| Secondary | Time Subjects Remain Normokalemic (Subacute Phase) | Through 18 days (12 days treatment, 6 days follow-up) of subacute phase | Time (number of days) subjects remain normokalemic (3.5 - 5.0 mmol/l) subacute phase |
| Secondary | Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase | Through 18 days of subacute phase (12 days treatment, 6 days follow-up) | Percentage of subjects within each treatment group who retained normal S-K values (values between 3.5-5.0 mmol/L) at end of subacute phase |
| Secondary | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Through 18 days of subacute phase (12 days treatment, 6 days follow-up) | Mean change from subacute baseline in serum potassium at all time points during subacute phase |
| Secondary | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Through 18 days of subacute phase (12 days treatment, 6 days follow-up) | Mean percent change from subacute baseline in serum potassium at all time points during subacute phase |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Through 48 hours acute phase | ITT Population | log(mmol/L)/hour | MEAN |
| PRIMARY | Exponential Rate of Change in S-K Levels in the Subacute Phase. | Through 12 days subacute phase (Day 3 through Day 15) | ITT population. One subject in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population | log(mmol/L)/hour | MEAN |
| SECONDARY | Percentage of Subjects Who Achieve Normalization in S-K Levels After 48 Hours of Treatment | Through 48 hours acute phase | Subjects from ITT population who have completed Acute phase | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in S-K at All Time Points Acute Phase | Through 48 hours acute phase. In particular, at Baseline; 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3. | ITT population | mmol/L | MEAN |
| SECONDARY | Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase | Through 48 hours acute phase. In particular, 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3. | ITT population | percentage | MEAN |
| SECONDARY | Time Subjects Remain Normokalemic (Subacute Phase) | Through 18 days (12 days treatment, 6 days follow-up) of subacute phase | ITT population. One subject (087-025) in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population | Days | MEAN |
| SECONDARY | Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase | Through 18 days of subacute phase (12 days treatment, 6 days follow-up) | ITT population. One subject (087-025) in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Subacute Baseline in Serum Potassium at All Time Points. | Through 18 days of subacute phase (12 days treatment, 6 days follow-up) | ITT population. One subject (087-025) in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population | mmol/L | MEAN |
| SECONDARY | Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points. | Through 18 days of subacute phase (12 days treatment, 6 days follow-up) | ITT population. One subject (087-025) in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population | percentage | MEAN |
Source ClinicalTrials.gov
Results by group270
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Acute Phase: Placebo TID | Through 24 Hours | -0.00128 | Standard Error 0.000243 | log(mmol/L)/hour |
| Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Through 24 Hours | -0.00187 | Standard Error 0.000250 | log(mmol/L)/hour |
| Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Acute Phase: ZS 2.5 g TID | Through 24 Hours | -0.00205 | Standard Error 0.000263 | log(mmol/L)/hour |
| Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Acute Phase: ZS 5 g TID | Through 24 Hours | -0.00280 | Standard Error 0.000250 | log(mmol/L)/hour |
| Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Acute Phase: ZS 10 g TID | Through 24 Hours | -0.00382 | Standard Error 0.000258 | log(mmol/L)/hour |
| Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Acute Phase: Placebo TID | Through 48 Hours | -0.00097 | Standard Error 0.000137 | log(mmol/L)/hour |
| Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | Through 48 Hours | -0.00110 | Standard Error 0.000141 | log(mmol/L)/hour |
| Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Acute Phase: ZS 2.5 g TID | Through 48 Hours | -0.00163 | Standard Error 0.000148 | log(mmol/L)/hour |
| Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Acute Phase: ZS 5 g TID | Through 48 Hours | -0.00223 | Standard Error 0.000141 | log(mmol/L)/hour |
| Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. | Acute Phase: ZS 10 g TID | Through 48 Hours | -0.00321 | Standard Error 0.000145 | log(mmol/L)/hour |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 results by groupParticipant flow90
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Acute Phase-Initial 48 Hours | STARTED | Acute Phase: Placebo | 158 | |
| Acute Phase-Initial 48 Hours | STARTED | Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | 154 | |
| Acute Phase-Initial 48 Hours | STARTED | Acute Phase: ZS 2.5 g TID | 141 | |
| Acute Phase-Initial 48 Hours | STARTED | Acute Phase: ZS 5 g TID | 158 | |
| Acute Phase-Initial 48 Hours | STARTED | Acute Phase: ZS 10 TID | 143 | |
| Acute Phase-Initial 48 Hours | STARTED | Subacute Phase: Placebo Matched to ZS 1.25g QD | 0 | |
| Acute Phase-Initial 48 Hours | STARTED | Subacute Phase: ZS 1.25 g QD | 0 | |
| Acute Phase-Initial 48 Hours | STARTED | Subacute Phase: Placebo Matched to ZS 2.5 g QD | 0 | |
| Acute Phase-Initial 48 Hours | STARTED | Subacute Phase: ZS 2.5 g QD | 0 | |
| Acute Phase-Initial 48 Hours | STARTED | Subacute Phase: Placebo Matched to ZS 5 g QD | 0 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 participant flowAdverse events645
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 | Atrial fibrilliation | Cardiac disorders | Acute Phase: Placebo TID | 0 | 158 | |
| other | Atrial fibrilliation | Cardiac disorders | Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | 0 | 154 | |
| other | Atrial fibrilliation | Cardiac disorders | Acute Phase: ZS 2.5 g TID | 0 | 141 | |
| other | Atrial fibrilliation | Cardiac disorders | Acute Phase: ZS 5 g TID | 0 | 157 | |
| other | Atrial fibrilliation | Cardiac disorders | Acute Phase: ZS 10 TID | 0 | 143 | |
| other | Atrial fibrilliation | Cardiac disorders | Subacute Phase: Placebo Matched to ZS 1.25g QD | 0 | 41 | |
| other | Atrial fibrilliation | Cardiac disorders | Subacute Phase: ZS 1.25 g QD | 0 | 49 | |
| other | Atrial fibrilliation | Cardiac disorders | Subacute Phase: Placebo Matched to ZS 2.5 g QD | 0 | 46 | |
| other | Atrial fibrilliation | Cardiac disorders | Subacute Phase: ZS 2.5 g QD | 0 | 54 | |
| other | Atrial fibrilliation | Cardiac disorders | Subacute Phase: Placebo Matched to ZS 5 g QD | 1 | 68 |
1 to 10 of 645Source ClinicalTrials.gov
See all 645 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acute Phase: Placebo TID | ||
| Total, all-cause mortality | Acute Phase: Sodium Zirconium Cyclosilicate (ZS) 1.25 g TID | ||
| Total, all-cause mortality | Acute Phase: ZS 2.5 g TID | ||
| Total, all-cause mortality | Acute Phase: ZS 5 g TID | ||
| Total, all-cause mortality | Acute Phase: ZS 10 TID | ||
| Total, all-cause mortality | Subacute Phase: Placebo Matched to ZS 1.25g QD | ||
| Total, all-cause mortality | Subacute Phase: ZS 1.25 g QD | ||
| Total, all-cause mortality | Subacute Phase: Placebo Matched to ZS 2.5 g QD | ||
| Total, all-cause mortality | Subacute Phase: ZS 2.5 g QD | ||
| Total, all-cause mortality | Subacute Phase: Placebo Matched to ZS 5 g QD |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse event totalsPapers4
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/NCT01737697
GET https://conductscience.org/api/trials/v1/NCT01737697/results?page=2