Hyperkalemia
Conditions
Brief summary
This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.
Detailed description
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.
Interventions
DRUGpatiromer
15 grams/day (5 grams 3 times daily) administered orally
Sponsors
Relypsa, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participants on hemodialysis between the ages of 18 and 70 years, with serum potassium levels of at least 5.5 mmol/L * Adequately dialyzed (Kt/V ≥ 1.2)
Exclusion criteria
* History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery. * Severe constipation or irregular bowel habits. * Unable to consume or tolerate the study-specific diet.
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Patiromer 15 grams/day (5 grams 3 times daily) patiromer administered orally | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Patiromer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 49.7 years |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7)
Time frame: Day -7 Through Day -1 and Day 1 Through Day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patiromer | Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7) | 359 mg/Day | Standard Deviation 277 |
p-value: =0.02paired t-test
Primary
Change in Serum Potassium (Day 1 to Day 8)
Time frame: Day 1 and Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patiromer | Change in Serum Potassium (Day 1 to Day 8) | -0.23 mmol/L | Standard Deviation 0.327 |
p-value: =0.14paired t-test