Hyperkalemia
Conditions
Keywords
Treatment of Hyperkalemia, Hyperkalemia, Potassium, Chronic Kidney Disease
Brief summary
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).
Detailed description
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.
Interventions
DRUGpatiromer
8.4 g/day starting dose, administered orally
Sponsors
Relypsa, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Potassium concentration \> 5.0 mEq/L from two blood draws at Screening * Stable RAASi medication, if taking * Medications taken on a chronic basis are given once daily or twice daily * Informed consent given Key
Exclusion criteria
* Expected need for dialysis * Major organ transplant * History of conditions associated with pseudohyperkalemia * History of swallowing disorder, gastroparesis, bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery * Cancer or unstable medical condition
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Serum Potassium From Baseline to Week 4 | Baseline to Day 28 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - Dosing Without Food Patiromer dosing without food
patiromer: 8.4 g/day starting dose, administered orally | 57 |
| 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. | 55 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Taking potassium supplement: exclusion 6 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Group 1 - Dosing Without Food | Group 2 - Dosing With Food | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 38 Participants | 35 Participants | 73 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 20 Participants | 39 Participants |
| Age, Continuous | 69 years | 66 years | 67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants | 30 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 25 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 48 Participants | 44 Participants | 92 Participants |
| Region of Enrollment United States | 57 participants | 55 participants | 112 participants |
| Sex: Female, Male Female | 17 Participants | 22 Participants | 39 Participants |
| Sex: Female, Male Male | 40 Participants | 33 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 57 | 0 / 56 |
| other Total, other adverse events | 4 / 57 | 8 / 56 |
| serious Total, serious adverse events | 4 / 57 | 1 / 56 |
Outcome results
Primary
Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4
Time frame: 21 to 28 Days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 - Dosing Without Food | Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 | 82.5 percentage of participants |
| Group 2 - Dosing With Food | Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 | 87.3 percentage of participants |
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.
Time frame: Baseline to Day 28
Population: Only intent-to-treat subjects who were available at both Baseline and Week 4 visits.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group 1 - Dosing Without Food | Mean Change in Serum Potassium From Baseline to Week 4 | -0.62 mEq/L | Standard Error 0.094 |
| Group 2 - Dosing With Food | Mean Change in Serum Potassium From Baseline to Week 4 | -0.65 mEq/L | Standard Error 0.088 |
Comparison: Estimation of mean change in serum potassium from Baseline to week 4.p-value: 0.789395% CI: [-0.17, 0.22]ANCOVA