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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001956-20 | EudraCT Number |
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The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.
There were two parts in the study, Part A and Part B.
Part A was an assessment of 4 weeks of dosing with patiromer in the treatment of hyperkalemia; Part B was a randomized, placebo-controlled, 8-week assessment of the withdrawal of patiromer in participants with a baseline serum potassium at the beginning of Part A ≥ 5.5 mEq/L who responded to the 4 weeks of treatment with patiromer during Part A.
All participants received patiromer during Part A; Part B participants were randomized to continue patiromer or switch to placebo. Total study participation was up to 14 weeks (including up to 2 weeks of follow up).
The dose of patiromer could be titrated based on participant's serum potassium response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patiromer | Active Comparator | Patiromer was administered twice a day as a powder mixed with water. |
|
| Placebo | Placebo Comparator | Placebo was administered twice a day as a powder mixed with water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patiromer | Drug |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Potassium From 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). | Part A Baseline to Part A Week 4 |
| Change in Serum Potassium From Part B Baseline | 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. | Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L |
| Measure | Description | Time Frame |
|---|---|---|
| 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 That Was ≥ 5.5 mEq/L in Part B | Part B Baseline to Part B Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director Clinical Operations | Relypsa, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 3121 | Azusa | California | 91702 | United States | ||
| Investigator Site 3133 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25415805 | Background | Weir MR, Bakris GL, Bushinsky DA, Mayo MR, Garza D, Stasiv Y, Wittes J, Christ-Schmidt H, Berman L, Pitt B; OPAL-HK Investigators. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med. 2015 Jan 15;372(3):211-21. doi: 10.1056/NEJMoa1410853. Epub 2014 Nov 21. | |
| 32588430 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A Patiromer | Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks. |
| FG001 | Part B Patiromer |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A Treatment Period |
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| Placebo |
| Drug |
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| Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B | Part B Baseline to Part B Week 8 |
| Los Angeles |
| California |
| 90025 |
| United States |
| Investigator Site 3103 | Sacramento | California | 95825 | United States |
| Investigator Site 3129 | Santa Barbara | California | 93110 | United States |
| Investigator Site 3130 | Ventura | California | 93003 | United States |
| Investigator Site 3105 | Edgewater | Florida | 32132 | United States |
| Investigator Site 3113 | Hollywood | Florida | 33021 | United States |
| Investigator Site 3106 | Port Charlotte | Florida | 33952 | United States |
| Investigator Site 3120 | Augusta | Georgia | 30909 | United States |
| Investigator Site 3102 | Farmington | Missouri | 63640 | United States |
| Investigator Site 3104 | Kansas City | Missouri | 64111 | United States |
| Investigator Site 3134 | Flushing | New York | 11355 | United States |
| Investigator Site 3107 | Bethlehem | Pennsylvania | 18017 | United States |
| Investigator Site 3110 | San Antonio | Texas | 78229 | United States |
| Investigator Site 1103 | Karlovac | 47000 | Croatia |
| Investigator Site 1102 | Osijek | 31000 | Croatia |
| Investigator Site 1104 | Zagreb | 10000 | Croatia |
| Investigator Site 1105 | Zagreb | 10000 | Croatia |
| Investigator Site 1106 | Zagreb | 10000 | Croatia |
| Investigator Site 1205 | Znojmo | 66 902 | Czechia |
| Investigator Site 2103 | Aarhus N | 8200 | Denmark |
| Investigator Site 2107 | Fredericia | 7000 | Denmark |
| Investigator Site 2101 | Roskilde | 4000 | Denmark |
| Investigator Site 2105 | Viborg | 8800 | Denmark |
| Investigator Site 1308 | Tbilisi | 0102 | Georgia |
| Investigator Site 1312 | Tbilisi | 0144 | Georgia |
| Investigator Site 1301 | Tbilisi | 0159 | Georgia |
| Investigator Site 1302 | Tbilisi | 0159 | Georgia |
| Investigator Site 1304 | Tbilisi | 0159 | Georgia |
| Investigator Site 1305 | Tbilisi | 0159 | Georgia |
| Investigator Site 1306 | Tbilisi | 0159 | Georgia |
| Investigator Site 1307 | Tbilisi | 0159 | Georgia |
| Investigator Site 1309 | Tbilisi | 0159 | Georgia |
| Investigator Site 1310 | Tbilisi | 0159 | Georgia |
| Investigator Site 1311 | Tbilisi | 0159 | Georgia |
| Investigator Site 1303 | Tbilisi | 0186 | Georgia |
| Investigator Site 1410 | Balatonfüred | H-8230 | Hungary |
| Investigator Site 1415 | Budapest | H-1133 | Hungary |
| Investigator Site 1401 | Győr | H-9024 | Hungary |
| Investigator Site 1406 | Hatvan | H-3000 | Hungary |
| Investigator Site 1405 | Jászberény | H-5100 | Hungary |
| Investigator Site 1411 | Kistarcsa | H-2143 | Hungary |
| Investigator Site 1407 | Veszprém | H-8200 | Hungary |
| Investigator Site 2201 | Pavia | 27100 | Italy |
| Investigator Site 1703 | Belgrade | 11000 | Serbia |
| Investigator Site 1710 | Vršac | 26300 | Serbia |
| Investigator Site 1707 | Zrenjanin | 23000 | Serbia |
| Investigator Site 1802 | Celje | 3000 | Slovenia |
| Investigator Site 1803 | Jesenice | 4270 | Slovenia |
| Investigator Site 1915 | Ivano-Frankivsk | 76018 | Ukraine |
| Investigator Site 1904 | Kharkiv | 61007 | Ukraine |
| Investigator Site 1903 | Kharkiv | 61018 | Ukraine |
| Investigator Site 1908 | Kharkiv | 61039 | Ukraine |
| Investigator Site 1909 | Kyiv | 04114 | Ukraine |
| Investigator Site 1911 | Kyiv | 3680 | Ukraine |
| Investigator Site 1914 | Luhansk | 91045 | Ukraine |
| Investigator Site 1907 | Zaporizhzhia | 69001 | Ukraine |
| Investigator Site 1906 | Zaporizhzhia | 69118 | Ukraine |
| Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2. |
Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
| FG002 | Part B Placebo | Participants were administered placebo orally twice a day for 8 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| Part B Placebo-Controlled Withdrawal |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A Patiromer | Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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 | Proportion of participants with serum potassium level in the target range at Part A Week 4 | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
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| Secondary | Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B | Posted | Number | percentage of participants | Part B Baseline to Part B Week 8 |
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| Secondary | Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B | 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. | Posted | Number | percentage of participants | Part B Baseline to Part B Week 8 |
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| Primary | Change in Serum Potassium From 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). | Posted | Least Squares Mean | Standard Error | mEq/L | Part A Baseline to Part A Week 4 |
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| Primary | Change in Serum Potassium From Part B Baseline | 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. | Posted | Median | Inter-Quartile Range | mEq/L | Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L |
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2 weeks after Week 4 for Part A subjects who did not continue in Part B and 2 weeks after Week 12 for Part B.
Participants who received at least one dose of trial medication
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A Patiromer | Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks. | 3 | 243 | 33 | 243 | ||
| EG001 | Part B Patiromer | Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks. | 0 | 55 | 5 | 55 | ||
| EG002 | Part B Placebo | Participants were administered placebo orally twice a day for 8 weeks. | 1 | 52 | 8 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anticoagulation drug level below therapeutic | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Thrombosis mesenteric vessel | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Renal failure chronic | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
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| Escherichia bacteraemia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Endocarditis enterococcal | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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Our agreements generally provide that PI cannot publish single site data before publication of the multi-site publication, unless 1 year has elapsed since completion of the study at all sites. Thereafter, PI may publish provided that PI shall: provide a copy of the publication to sponsor at least 60 days in advance of submission for publication; delete sponsor's confidential information as requested; and delay publication up to an additional 90 days to permit protection of intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Relypsa, Inc. | 1-844-relypsa | medinfo@relypsa.com |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C568789 | patiromer |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Adverse Event |
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| Death |
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| Withdrawal by Subject |
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| Protocol-specified (eGFR) |
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| Protocol-specified (K+ result) |
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| Protocol-specified (High K+) |
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| Protocol-specified (Low K+) |
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