Trial · NCT02694744
Patiromer With or Without Food for the Treatment of Hyperkalemia
NCT02694744, Phase 4, Completed, Relypsa, Inc.; results first posted 2017-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Patiromer With or Without Food for the Treatment of Hyperkalemia. Trials, record NCT02694744. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02694744
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patiromer With or Without Food for the Treatment of Hyperkalemia
- NCT number
- NCT02694744
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 114 participants, actual
- Lead sponsor
- Relypsa, Inc.
- Conditions
- Hyperkalemia
- Interventions
- patiromer
- First posted
- 2016-02-29
- Last updated
- 2021-05-12
- Results first posted
- 2017-11-20
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 | 21 to 28 Days | |
| Secondary | Mean Change in Serum Potassium From Baseline to Week 4 | Baseline to Day 28 | An ANCOVA model was used to estimate the mean serum potassium change from Baseline to Week 4 with baseline serum potassium as a covariate and treatment group, race (white vs all others), and history of Type 1 or 2 diabetes mellitus (yes or no) as factors in the model. |
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 | Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 | 21 to 28 Days | The intent-to-treat (ITT) population for efficacy analyses includes all subjects who have been randomized and have taken at least one dose of patiromer. | percentage of participants | NUMBER |
| SECONDARY | Mean Change in Serum Potassium From Baseline to Week 4 | Baseline to Day 28 | Only intent-to-treat subjects who were available at both Baseline and Week 4 visits. | mEq/L | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 | Group 1 - Dosing Without Food | 82.5 | 95% Confidence Interval 70.1 to 91.3 | percentage of participants | |
| Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 | Group 2 - Dosing With Food | 87.3 | 95% Confidence Interval 75.5 to 94.7 | percentage of participants | |
| Mean Change in Serum Potassium From Baseline to Week 4 | Group 1 | -0.62 | Standard Error 0.094 | mEq/L | |
| Mean Change in Serum Potassium From Baseline to Week 4 | Group 2 | -0.65 | Standard Error 0.088 | mEq/L |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 - Dosing Without Food | 57 | |
| Overall Study | STARTED | Group 2 - Dosing With Food | 57 | |
| Overall Study | Safety Population | Group 1 - Dosing Without Food | 57 | |
| Overall Study | Safety Population | Group 2 - Dosing With Food | 56 | |
| Overall Study | ITT | Group 1 - Dosing Without Food | 57 | |
| Overall Study | ITT | Group 2 - Dosing With Food | 55 | |
| Overall Study | COMPLETED | Group 1 - Dosing Without Food | 51 | |
| Overall Study | COMPLETED | Group 2 - Dosing With Food | 52 | |
| Overall Study | NOT COMPLETED | Group 1 - Dosing Without Food | 6 | |
| Overall Study | NOT COMPLETED | Group 2 - Dosing With Food | 5 |
Source ClinicalTrials.gov
Adverse events16
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 | Diarrhoea | Gastrointestinal disorders | Group 1 - Dosing Without Food | 3 | 57 | |
| other | Diarrhoea | Gastrointestinal disorders | Group 2 - Dosing With Food | 3 | 56 | |
| other | Headache | Nervous system disorders | Group 1 - Dosing Without Food | 0 | 57 | |
| other | Headache | Nervous system disorders | Group 2 - Dosing With Food | 3 | 56 | |
| other | Blood Creatine Phosphokinase Increased | Investigations | Group 1 - Dosing Without Food | 1 | 57 | |
| other | Blood Creatine Phosphokinase Increased | Investigations | Group 2 - Dosing With Food | 3 | 56 | |
| serious | Angina pectoris | Cardiac disorders | Group 1 - Dosing Without Food | 0 | 57 | |
| serious | Angina pectoris | Cardiac disorders | Group 2 - Dosing With Food | 1 | 56 | |
| serious | Cardio-respiratory arrest | Cardiac disorders | Group 1 - Dosing Without Food | 1 | 57 | |
| serious | Cardio-respiratory arrest | Cardiac disorders | Group 2 - Dosing With Food | 0 | 56 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 - Dosing Without Food | 1 | 57 |
| Total, all-cause mortality | Group 2 - Dosing With Food | 0 | 56 |
| Total, other adverse events | Group 1 - Dosing Without Food | 4 | 57 |
| Total, other adverse events | Group 2 - Dosing With Food | 8 | 56 |
| Total, serious adverse events | Group 1 - Dosing Without Food | 4 | 57 |
| Total, serious adverse events | Group 2 - Dosing With Food | 1 | 56 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32588430 | 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 |
|---|---|
| Group 1 - Dosing Without Food vs Group 2 - Dosing With Food: deaths from any cause | Trial comparisons |
| Group 1 - Dosing Without Food vs Group 2 - Dosing With Food: 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/NCT02694744
GET https://conductscience.org/api/trials/v1/NCT02694744/registered