A Phase 4 interventional study of patiromer in Hyperkalemia, sponsored by Relypsa, Inc.. Completed at 29 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-12.
Sponsored by Relypsa, Inc. · Phase 4, Interventional, and Treatment
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.
122 studies on the registry are indexed under Hyperkalemia; 24 are open to participants now.
This study's enrollment of 114 is above the median of 80 across 92 interventional studies indexed under Hyperkalemia.
Browse Hyperkalemia studies →Relypsa, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Patiromer dosing without food
Drug: patiromer
Patiromer dosing with food
Drug: patiromer
8.4 g/day starting dose, administered orally
Also known as: Veltassa, RLY5016 for Oral Suspension
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
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
| Milestone | Group 1 - Dosing Without Food | Group 2 - Dosing With Food |
|---|---|---|
| Started | 57 | 57 |
| Safety population | 57 | 56 |
| Itt | 57 | 55 |
| Completed | 51 | 52 |
| Not completed | 6 | 5 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Physician decision | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Taking potassium supplement: exclusion 6 | 0 | 1 |
| percentage of participants | Group 1 - Dosing Without Food | 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 | 82.5 (70.1 to 91.3) | 87.3 (75.5 to 94.7) |
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.
| mEq/L | Group 1 | Group 2 |
|---|---|---|
| Mean Change in Serum Potassium From Baseline to Week 4 | -0.62 ± 0.094 | -0.65 ± 0.088 |
Collected over Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 - Dosing Without Food | 1/57 (1.8%) | 4/57 (7%) | 4/57 (7%) |
| Group 2 - Dosing With Food | 0/56 (0%) | 1/56 (1.8%) | 8/56 (14.3%) |
| Event | Group 1 - Dosing Without Food | Group 2 - Dosing With Food |
|---|---|---|
| Angina pectorisCardiac disorders | 0/57 | 1/56 |
| Cardio-respiratory arrestCardiac disorders | 1/57 | 0/56 |
| AnaemiaBlood and lymphatic system disorders | 1/57 | 0/56 |
| Acute kidney injuryRenal and urinary disorders | 1/57 | 0/56 |
| Intermittent claudicationVascular disorders | 1/57 | 0/56 |
| Event | Group 1 - Dosing Without Food | Group 2 - Dosing With Food |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 3/57 | 3/56 |
| HeadacheNervous system disorders | 0/57 | 3/56 |
| Blood Creatine Phosphokinase IncreasedInvestigations | 1/57 | 3/56 |
The intent-to-treat (ITT) population for analysis included all subjects who were randomized and had taken at least one dose of patiromer.
| Age, Categorical(Participants) | Group 1 - Dosing Without Food | Group 2 - Dosing With Food | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 20 | 39 |
| >=65 years | 38 | 35 | 73 |
| Age, Continuous(years) | Group 1 - Dosing Without Food | Group 2 - Dosing With Food | Total |
|---|---|---|---|
| Median | 69 (26 to 89) | 66 (48 to 94) | 67 (26 to 94) |
| Sex: Female, Male(Participants) | Group 1 - Dosing Without Food | Group 2 - Dosing With Food | Total |
|---|---|---|---|
| Female | 17 | 22 | 39 |
| Male | 40 | 33 | 73 |
| Ethnicity (NIH/OMB)(Participants) | Group 1 - Dosing Without Food | Group 2 - Dosing With Food | Total |
|---|---|---|---|
| Hispanic or Latino | 33 | 30 | 63 |
| Not Hispanic or Latino | 24 | 25 | 49 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group 1 - Dosing Without Food | Group 2 - Dosing With Food | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 8 | 14 |
| White | 48 | 44 | 92 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Region of Enrollment(participants) | Group 1 - Dosing Without Food | Group 2 - Dosing With Food | Total |
|---|---|---|---|
| United States | 57 | 55 | 112 |
Plan to share: No
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Relypsa, Inc.