Trial · NCT01371747
Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)
NCT01371747, Phase 2, Completed, Relypsa, Inc.; results first posted 2015-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN). Trials, record NCT01371747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01371747
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)
- NCT number
- NCT01371747
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 324 participants, actual
- Lead sponsor
- Relypsa, Inc.
- Conditions
- Chronic Kidney Disease, Hypertension, Hyperkalemia
- Interventions
- patiromer, patiromer, patiromer, patiromer, patiromer, patiromer, losartan, spironolactone
- First posted
- 2011-06-13
- Last updated
- 2021-06-03
- Other registries' IDs
- eudract:2011-000165-12
- Results first posted
- 2015-12-17
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group | Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation. | Least square mean changes from Baseline to Week 4/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates. |
| Secondary | Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group | Baseline to Week 8 or First Titration which could occur at any scheduled study visit after patiromer initiation. | Least squares mean changes from Baseline to Week 8/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates. |
| Secondary | Least Squares Mean Change in Serum Potassium From Baseline to Day 3 During the Treatment Initiation Period for Each Individual Starting Dose Group | Baseline to Day 3 | Least squares mean changes from Baseline to Day 3 were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates. |
| Secondary | Mean Change in Serum Potassium From Baseline to Week 52 During the Long-term Maintenance Period for Each Individual Starting Dose Group | Baseline to Week 52 | |
| Secondary | Mean Change in Serum Potassium From Week 52 or Last Patiromer Dose (if Occurred Before Week 52) to Follow-up Visits Plus 7 Days | Week 52 or Last Patiromer Dose (if Occurred before Week 52) to Following up Visit Plus 7 Days | |
| Secondary | Proportion of Participants Achieving Serum Potassium Levels Within 3.5 to 5.5 mEq/L at Week 8 for Each Individual Starting Dose Group | Baseline to Week 8 | |
| Secondary | Proportion of Participants Achieving Serum Potassium Levels Within 4.0 to 5.0 mEq/L at Week 8 for Each Individual Starting Dose Group | Baseline to Week 8 | |
| Secondary | Time to First Serum Potassium Measurement of 4.0 - 5.0 mEq/L During Treatment Initiation Period for Each Individual Starting Dose Group | Baseline to Week 8 | |
| Secondary | Proportions of Participants Achieving Serum Potassium Levels Within 3.8 to 5.0 mEq/L at Week 52 for Each Individual Starting Dose Group | Baseline to Week 52 |
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 | Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group | Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation. | Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest. | mEq/L | LEAST_SQUARES_MEAN |
| SECONDARY | Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group | Baseline to Week 8 or First Titration which could occur at any scheduled study visit after patiromer initiation. | Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest. | mEq/L | LEAST_SQUARES_MEAN |
| SECONDARY | Least Squares Mean Change in Serum Potassium From Baseline to Day 3 During the Treatment Initiation Period for Each Individual Starting Dose Group | Baseline to Day 3 | Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest. | mEq/L | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Serum Potassium From Baseline to Week 52 During the Long-term Maintenance Period for Each Individual Starting Dose Group | Baseline to Week 52 | Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest. | mEq/L | MEAN |
| SECONDARY | Mean Change in Serum Potassium From Week 52 or Last Patiromer Dose (if Occurred Before Week 52) to Follow-up Visits Plus 7 Days | Week 52 or Last Patiromer Dose (if Occurred before Week 52) to Following up Visit Plus 7 Days | Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest. | mEq/L | MEAN |
| SECONDARY | Proportion of Participants Achieving Serum Potassium Levels Within 3.5 to 5.5 mEq/L at Week 8 for Each Individual Starting Dose Group | Baseline to Week 8 | Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants Achieving Serum Potassium Levels Within 4.0 to 5.0 mEq/L at Week 8 for Each Individual Starting Dose Group | Baseline to Week 8 | Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest. | percentage of participants | NUMBER |
| SECONDARY | Time to First Serum Potassium Measurement of 4.0 - 5.0 mEq/L During Treatment Initiation Period for Each Individual Starting Dose Group | Baseline to Week 8 | Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest. | Days | MEDIAN |
| SECONDARY | Proportions of Participants Achieving Serum Potassium Levels Within 3.8 to 5.0 mEq/L at Week 52 for Each Individual Starting Dose Group | Baseline to Week 52 | Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group | Stratum 1: 8.4 g/d Patiromer | -0.35 | Standard Error 0.066 | mEq/L | |
| Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group | Stratum 1: 16.8 g/d Patiromer | -0.51 | Standard Error 0.067 | mEq/L | |
| Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group | Stratum 1: 25.2 g/d Patiromer | -0.55 | Standard Error 0.067 | mEq/L | |
| Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group | Stratum 2: 16.8 g/d Patiromer | -0.87 | Standard Error 0.134 | mEq/L | |
| Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group | Stratum 2: 25.2 g/d Patiromer | -0.97 | Standard Error 0.132 | mEq/L | |
| Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group | Stratum 2: 33.6 g/d Patiromer | -0.92 | Standard Error 0.125 | mEq/L | |
| Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group | Stratum 1: 8.4 g/d Patiromer | -0.35 | Standard Error 0.070 | mEq/L | |
| Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group | Stratum 1: 16.8 g/d Patiromer | -0.47 | Standard Error 0.070 | mEq/L | |
| Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group | Stratum 1: 25.2 g/d Patiromer | -0.54 | Standard Error 0.070 | mEq/L | |
| Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group | Stratum 2: 16.8 g/d Patiromer | -0.88 | Standard Error 0.142 | mEq/L |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum 1: 8.4 g/d Patiromer | 74 | |
| Overall Study | STARTED | Stratum 1: 16.8 g/d Patiromer | 74 | |
| Overall Study | STARTED | Stratum 1: 25.2 g/d Patiromer | 74 | |
| Overall Study | STARTED | Stratum 2: 16.8 g/d Patiromer | 26 | |
| Overall Study | STARTED | Stratum 2: 25.2 g/d Patiromer | 28 | |
| Overall Study | STARTED | Stratum 2: 33.6 g/d Patiromer | 30 | |
| Overall Study | COMPLETED | Stratum 1: 8.4 g/d Patiromer | 56 | |
| Overall Study | COMPLETED | Stratum 1: 16.8 g/d Patiromer | 51 | |
| Overall Study | COMPLETED | Stratum 1: 25.2 g/d Patiromer | 50 | |
| Overall Study | COMPLETED | Stratum 2: 16.8 g/d Patiromer | 17 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events324
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 | Anaemia | Blood and lymphatic system disorders | Stratum 1: 8.4 g/d Patiromer | 2 | 74 | |
| other | Anaemia | Blood and lymphatic system disorders | Stratum 1: 16.8 g/d Patiromer | 2 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | Stratum 1: 25.2 g/d Patiromer | 4 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | Stratum 2: 16.8 g/d Patiromer | 0 | 26 | |
| other | Anaemia | Blood and lymphatic system disorders | Stratum 2: 25.2 g/d Patiromer | 1 | 28 | |
| other | Anaemia | Blood and lymphatic system disorders | Stratum 2: 33.6 g/d Patiromer | 2 | 30 | |
| other | Angina pectoris | Cardiac disorders | Stratum 1: 8.4 g/d Patiromer | 0 | 74 | |
| other | Angina pectoris | Cardiac disorders | Stratum 1: 16.8 g/d Patiromer | 1 | 73 | |
| other | Angina pectoris | Cardiac disorders | Stratum 1: 25.2 g/d Patiromer | 2 | 73 | |
| other | Angina pectoris | Cardiac disorders | Stratum 2: 16.8 g/d Patiromer | 1 | 26 |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum 1: 8.4 g/d Patiromer | ||
| Total, all-cause mortality | Stratum 1: 16.8 g/d Patiromer | ||
| Total, all-cause mortality | Stratum 1: 25.2 g/d Patiromer | ||
| Total, all-cause mortality | Stratum 2: 16.8 g/d Patiromer | ||
| Total, all-cause mortality | Stratum 2: 25.2 g/d Patiromer | ||
| Total, all-cause mortality | Stratum 2: 33.6 g/d Patiromer | ||
| Total, other adverse events | Stratum 1: 8.4 g/d Patiromer | 28 | 74 |
| Total, other adverse events | Stratum 1: 16.8 g/d Patiromer | 29 | 73 |
| Total, other adverse events | Stratum 1: 25.2 g/d Patiromer | 29 | 73 |
| Total, other adverse events | Stratum 2: 16.8 g/d Patiromer | 14 | 26 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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
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