Trial · NCT01810939
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
NCT01810939, Phase 3, Completed, Relypsa, Inc.; results first posted 2015-12-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL). Trials, record NCT01810939. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01810939
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
- NCT number
- NCT01810939
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 243 participants, actual
- Lead sponsor
- Relypsa, Inc.
- Conditions
- Chronic Kidney Disease (CKD), Hyperkalemia (HK)
- Interventions
- Patiromer, Placebo
- First posted
- 2013-03-14
- Last updated
- 2021-06-03
- Other registries' IDs
- eudract:2012-001956-20
- Results first posted
- 2015-12-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Serum Potassium From Part A Baseline to Part A Week 4 | Part A Baseline to Part A Week 4 | The primary analysis endpoint is the change from Baseline at Week 4. The estimate of the change at Week 4 is from a repeated measures model, which includes data from Weeks 1, 2, 3 and 4. The analysis includes all intent to treat participants who had a serum potassium result at baseline and at least one weekly post-baseline visit (i.e. Part A Week 1 or later) and excludes six participants who had no result collected after Day 3). |
| Primary | Change in Serum Potassium From Part B Baseline | Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L | Change in Serum Potassium from Part B Baseline to either: Part B Week 4 visit, if the participant's serum potassium remained ≥ 3.8 mEq/L and \< 5.5 mEq/L up to the Part B Week 4 visit or the earliest Part B visit at which the participant's serum potassium was \< 3.8 mEq/L or ≥ 5.5 mEq/L. |
| Secondary | Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4 | Week 4 | |
| Secondary | Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B | Part B Baseline to Part B Week 8 | |
| Secondary | Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B | Part B Baseline to Part B Week 8 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4 | Week 4 | Proportion of participants with serum potassium level in the target range at Part A Week 4 | percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B | Part B Baseline to Part B Week 8 | percentage of participants | NUMBER | |
| SECONDARY | Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B | Part B Baseline to Part B Week 8 | Percentages were estimated not as simple ratios, but by using a stratified method, in order to account for differences between the patiromer and placebo groups in terms of whether participants had type 2 diabetes mellitus and whether they entered the study with serum potassium \< 5.8 mEq/L or serum potassium ≥ 5.8 mEq/L. | percentage of participants | NUMBER |
| PRIMARY | Change in Serum Potassium From Part A Baseline to Part A Week 4 | Part A Baseline to Part A Week 4 | mEq/L | LEAST_SQUARES_MEAN | |
| PRIMARY | Change in Serum Potassium From Part B Baseline | Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L | mEq/L | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4 | Part A Patiromer | 76 | 95% Confidence Interval 70 to 81 | percentage of participants | |
| Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B | Part B Placebo | 60 | percentage of participants | ||
| Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B | Part B Patiromer | 15 | percentage of participants | ||
| Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B | Part B Placebo | 91 | percentage of participants | ||
| Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B | Part B Patiromer | 43 | percentage of participants | ||
| Change in Serum Potassium From Part A Baseline to Part A Week 4 | Part A Patiromer | -1.01 | Standard Error 0.031 | mEq/L | |
| Change in Serum Potassium From Part B Baseline | Part B Placebo | 0.72 | Inter-Quartile Range 0.22 to 1.22 | mEq/L | |
| Change in Serum Potassium From Part B Baseline | Part B Patiromer | 0 | Inter-Quartile Range -0.3 to 0.3 | mEq/L |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A Treatment Period | STARTED | Part A Patiromer | 243 | |
| Part A Treatment Period | STARTED | Part B Patiromer | 0 | |
| Part A Treatment Period | STARTED | Part B Placebo | 0 | |
| Part A Treatment Period | COMPLETED | Part A Patiromer | 219 | |
| Part A Treatment Period | COMPLETED | Part B Patiromer | 0 | |
| Part A Treatment Period | COMPLETED | Part B Placebo | 0 | |
| Part A Treatment Period | NOT COMPLETED | Part A Patiromer | 24 | |
| Part A Treatment Period | NOT COMPLETED | Part B Patiromer | 0 | |
| Part A Treatment Period | NOT COMPLETED | Part B Placebo | 0 | |
| Part B Placebo-Controlled Withdrawal | STARTED | Part A Patiromer | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events33
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 | Hypertension | Vascular disorders | Part A Patiromer | 4 | 243 | |
| other | Hypertension | Vascular disorders | Part B Patiromer | 0 | 55 | |
| other | Hypertension | Vascular disorders | Part B Placebo | 3 | 52 | |
| other | Headache | Nervous system disorders | Part A Patiromer | 2 | 243 | |
| other | Headache | Nervous system disorders | Part B Patiromer | 2 | 55 | |
| other | Headache | Nervous system disorders | Part B Placebo | 4 | 52 | |
| other | Constipation | Gastrointestinal disorders | Part A Patiromer | 26 | 243 | |
| other | Constipation | Gastrointestinal disorders | Part B Patiromer | 2 | 55 | |
| other | Constipation | Gastrointestinal disorders | Part B Placebo | 0 | 52 | |
| other | Influenza | Infections and infestations | Part A Patiromer | 1 | 243 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A Patiromer | ||
| Total, all-cause mortality | Part B Patiromer | ||
| Total, all-cause mortality | Part B Placebo | ||
| Total, other adverse events | Part A Patiromer | 33 | 243 |
| Total, other adverse events | Part B Patiromer | 5 | 55 |
| Total, other adverse events | Part B Placebo | 8 | 52 |
| Total, serious adverse events | Part A Patiromer | 3 | 243 |
| Total, serious adverse events | Part B Patiromer | 0 | 55 |
| Total, serious adverse events | Part B Placebo | 1 | 52 |
Source ClinicalTrials.gov
Papers2
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/NCT01810939
GET https://conductscience.org/api/trials/v1/NCT01810939/events?page=2