Trial · NCT01866709
Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia
NCT01866709, Phase 4, Terminated, ZS Pharma, Inc.; results first posted 2014-09-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia. Trials, record NCT01866709. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01866709
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia
- NCT number
- NCT01866709
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 32 participants, actual
- Lead sponsor
- ZS Pharma, Inc.
- Conditions
- Hyperkalemia
- Interventions
- Sodium polystyrene sulfonate, Silicified microcrystalline cellulose
- First posted
- 2013-05-31
- Last updated
- 2014-09-03
- Results first posted
- 2014-09-03
- Limitations and caveats
- Due to the high frequency of adverse events in the SPS group, the independent Data Monitoring Committee (iDMC) recommended termination of the study.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Serum Potassium Levels From Baseline After Administration of Sodium Polystyrene Sulfonate (SPS) Three Times a Day Without Co-administration of Sorbitol; Determine Incidence of Adverse Events. | First 48 hours | To perform a controlled evaluation of the safety and efficacy of 15g of SPS administered 3 times daily for 48 hours (6 doses) in patients with hyperkalemia (serum potassium levels between 5.0 - 6.5 mmol/l) at baseline. |
| Secondary | Change in Serum Sodium, Magnesium, Calcium Levels From Baseline After Administration of SPS. | First 48 hours |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Serum Potassium Levels From Baseline After Administration of Sodium Polystyrene Sulfonate (SPS) Three Times a Day Without Co-administration of Sorbitol; Determine Incidence of Adverse Events. | First 48 hours | Study prematurely terminated for safety reasons; no statistical analyses were conducted. | ||
| SECONDARY | Change in Serum Sodium, Magnesium, Calcium Levels From Baseline After Administration of SPS. | First 48 hours | Study was prematurely terminated for safety reasons; no statistical analyses were conducted. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sodium Polystyrene Sulfonate | 15 | |
| Overall Study | STARTED | Silicified Microcrystalline Cellulose | 17 | |
| Overall Study | COMPLETED | Sodium Polystyrene Sulfonate | 14 | |
| Overall Study | COMPLETED | Silicified Microcrystalline Cellulose | 17 | |
| Overall Study | NOT COMPLETED | Sodium Polystyrene Sulfonate | 1 | |
| Overall Study | NOT COMPLETED | Silicified Microcrystalline Cellulose | 0 |
Source ClinicalTrials.gov
Adverse events18
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 | ST elevation | Cardiac disorders | Sodium Polystyrene Sulfonate | 1 | 15 | 1 |
| other | ST elevation | Cardiac disorders | Silicified Microcrystalline Cellulose | 0 | 17 | 0 |
| other | Bloating | Gastrointestinal disorders | Sodium Polystyrene Sulfonate | 1 | 15 | 1 |
| other | Bloating | Gastrointestinal disorders | Silicified Microcrystalline Cellulose | 0 | 17 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Sodium Polystyrene Sulfonate | 4 | 15 | 6 |
| other | Diarrhea | Gastrointestinal disorders | Silicified Microcrystalline Cellulose | 3 | 17 | 3 |
| other | Flatulence | Gastrointestinal disorders | Sodium Polystyrene Sulfonate | 3 | 15 | 3 |
| other | Flatulence | Gastrointestinal disorders | Silicified Microcrystalline Cellulose | 1 | 17 | 1 |
| other | Nausea | Gastrointestinal disorders | Sodium Polystyrene Sulfonate | 2 | 15 | 2 |
| other | Nausea | Gastrointestinal disorders | Silicified Microcrystalline Cellulose | 1 | 17 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sodium Polystyrene Sulfonate | ||
| Total, all-cause mortality | Silicified Microcrystalline Cellulose | ||
| Total, other adverse events | Sodium Polystyrene Sulfonate | 7 | 15 |
| Total, other adverse events | Silicified Microcrystalline Cellulose | 3 | 17 |
| Total, serious adverse events | Sodium Polystyrene Sulfonate | 2 | 15 |
| Total, serious adverse events | Silicified Microcrystalline Cellulose | 0 | 17 |
Source ClinicalTrials.gov
Papers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sodium Polystyrene Sulfonate vs Silicified Microcrystalline Cellulose: serious adverse events |
Source 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/NCT01866709
GET https://conductscience.org/api/trials/v1/NCT01866709/registered