Phase 4
Completed N=114
Patiromer With or Without Food for the Treatment of Hyperkalemia
Source: ClinicalTrials.gov NCT02694744 ↗Enrolled (actual)
114
Serious AEs
4.4%
Results posted
Nov 2017
Primary outcomePrimary: 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; 87.3 percentage of participants
◆ Published Evidence
Established
46citations · ~8 / year
Potassium binders for chronic hyperkalaemia in people with chronic kidney disease.
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).
Linked Publications
-
Potassium binders for chronic hyperkalaemia in people with chronic kidney disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 87.3 | — |
| SECONDARY Mean Change in Serum Potassium From Baseline to Week 4 |
-0.62; -0.65 | 0.7893 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02694744) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.