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Study terminated due to slow enrollment
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This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.
The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study.
This was an open-label, multiple-dose, adaptive-design study in participants on hemodialysis. Eligible participants on hemodialysis were to remain in the Clinical Research Unit for 2 weeks (Day -7 to Day 8) and were required to consume a potassium, magnesium, calcium and sodium-controlled diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patiromer | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patiromer | Drug | 15 grams/day (5 grams 3 times daily) administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Potassium (Day 1 to Day 8) | Day 1 and Day 8 | |
| Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7) | Day -7 Through Day -1 and Day 1 Through Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| VP Clinical Development | Relypsa, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Orlando | Florida | 32809 | United States | ||
| Investigator Site |
The study population consisted of participants on hemodialysis between the ages of 18 and 70 years, with pre-dialysis serum potassium levels of at least 5.5 mmol/L prior to the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patiromer | 15 grams/day (5 grams 3 times daily) patiromer administered orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patiromer | 15 grams/day (5 grams 3 times daily) patiromer administered orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Serum Potassium (Day 1 to Day 8) | Posted | Mean | Standard Deviation | mmol/L | Day 1 and Day 8 |
|
|
Up to 10 days after Day 8 or last patiromer dose, whichever was earlier.
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 | Patiromer | 15 grams/day (5 grams 3 times daily) patiromer administered orally. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Rigidity | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Relypsa, Inc. | 1-844-relypsa | medinfo@relypsa.com |
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| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| 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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| Minneapolis |
| Minnesota |
| 55404 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7) | Posted | Mean | Standard Deviation | mg/Day | Day -7 Through Day -1 and Day 1 Through Day 7 |
|
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
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.