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The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high potassium in the blood).
Approximately 110 eligible participants with hyperkalemia will be randomly assigned to receive a patiromer starting dose of 8.4- g/day, either with or without food.
All participants will undergo a screening period (1 day) to determine eligibility for study entry. Eligible participants will be treated for 4 weeks and followed for 2 weeks after completing the patiromer treatment. There are six planned clinic visits during the Treatment Period and two planned visits after the last dose of patiromer during the Follow-up Period.
The dose of patiromer may be increased or decreased (titrated) based on participants' individual potassium response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Dosing Without Food | Experimental | Patiromer dosing without food |
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| Group 2 - Dosing With Food | Active Comparator | Patiromer dosing with food |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patiromer | Drug | 8.4 g/day starting dose, administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Serum Potassium From Baseline to Week 4 | 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. | Baseline to Day 28 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director or VP Clinical Development | Relypsa, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 12 | Fountain Valley | California | 92708 | United States | ||
| Investigator Site 11 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32588430 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Dosing Without Food | Patiromer dosing without food patiromer: 8.4 g/day starting dose, administered orally |
| FG001 | Group 2 - Dosing With Food | Patiromer dosing with food patiromer: 8.4 g/day starting dose, administered orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Huntington Beach |
| California |
| 92648 |
| United States |
| Investigator Site 38 | Palm Springs | California | 92262 | United States |
| Investigator Site 20 | Riverside | California | 92505 | United States |
| Investigator Site 21 | San Dimas | California | 91773 | United States |
| Investigator Site 24 | Denver | Colorado | 80230 | United States |
| Investigator Site 30 | Edgewater | Florida | 32132 | United States |
| Investigator Site 10 | Hialeah | Florida | 33012 | United States |
| Investigator Site 13 | Hollywood | Florida | 33021 | United States |
| Investigator Site 17 | Lauderdale Lakes | Florida | 33313-1638 | United States |
| Investigator Site 16 | Lauderdale Lakes | Florida | 33319 | United States |
| Investigator Site 15 | Miami | Florida | 33015 | United States |
| Investigator Site 43 | Miami | Florida | 33147 | United States |
| Investigator Site 18 | Pembroke Pines | Florida | 33028 | United States |
| Investigator Site 27 | Tampa | Florida | 33614 | United States |
| Investigator Site 44 | Meridian | Idaho | 83642 | United States |
| Investigator Site 39 | Aurora | Illinois | 60504 | United States |
| Investigator Site 23 | Flint | Michigan | 48504 | United States |
| Investigator Site 34 | Kansas City | Missouri | 64111 | United States |
| Investigator Site 41 | Las Vegas | Nevada | 89106 | United States |
| Investigator Site 37 | Flushing | New York | 11355 | United States |
| Investigator Site 36 | Norman | Oklahoma | 73069 | United States |
| Investigator Site 40 | Jackson | Tennessee | 38305 | United States |
| Investigator Site 33 | Dallas | Texas | 75231 | United States |
| Investigator Site 26 | San Antonio | Texas | 78202 | United States |
| Investigator Site 29 | San Antonio | Texas | 78207 | United States |
| Investigator Site 28 | San Antonio | Texas | 78215 | United States |
| Investigator Site 25 | San Antonio | Texas | 78229 | United States |
| Investigator Site 22 | Salt Lake City | Utah | 84124 | United States |
| Safety Population | Safety Population: All subjects who have taken at least one dose of patiromer. |
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| ITT | Two randomized participates from Group 2 were excluded from the analyses for the ITT population. |
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| COMPLETED |
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| NOT COMPLETED |
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The intent-to-treat (ITT) population for analysis included all subjects who were randomized and had taken at least one dose of patiromer.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Dosing Without Food | Patiromer dosing without food patiromer: 8.4 g/day starting dose, administered orally |
| BG001 | Group 2 - Dosing With Food | Patiromer dosing with food patiromer: 8.4 g/day starting dose, administered orally *Note: Two randomized participants in Group 2 -Dosing With Food were excluded from the analyses for the intent-to-treat (ITT) population. One participant who did not receive any patiromer dose. Another participant had an important protocol violation and had no post-baseline serum K+, and was excluded from ITT prior to unblinding. |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 21 to 28 Days |
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| Secondary | Mean Change in Serum Potassium From Baseline to Week 4 | 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. | Only intent-to-treat subjects who were available at both Baseline and Week 4 visits. | Posted | Least Squares Mean | Standard Error | mEq/L | Baseline to Day 28 |
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Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks.
Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.
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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 | Group 1 - Dosing Without Food | Patiromer dosing without food patiromer: 8.4 g/day starting dose, administered orally | 1 | 57 | 4 | 57 | 4 | 57 |
| EG001 | Group 2 - Dosing With Food | Patiromer dosing with food patiromer: 8.4 g/day starting dose, administered orally *Note - One randomized participant was excluded from the analysis as this participant did not receive any patiromer dose. | 0 | 56 | 1 | 56 | 8 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (18.1) | 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 |
|---|---|
| D006947 | Hyperkalemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| 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 |
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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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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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