Phase 4
Completed N=33
Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
Source: ClinicalTrials.gov NCT03781089 ↗Enrolled (actual)
33
Serious AEs
12.1%
Results posted
May 2025
Primary outcomePrimary: Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L — 13; 41 episodes — p=0.024
◆ 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 determine whether once-daily dosing of patiromer will reduce the frequency of hyperkalemic episodes in ESRD (end stage renal disease) study participants who receive conventional hemodialysis (HD). The study objective is to determine if patiromer administered orally once a day with breakfast or lunch will reduce episodes of hyperkalemia in ESRD study participants who receive thrice-weekly HD.
Linked Publications
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Potassium binders for chronic hyperkalaemia in people with chronic kidney disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L |
13; 41 | 0.024 sig |
| SECONDARY Number of Episodes of Serum Potassium ≥ 5.5 mEq/L Per Participant |
0; 3 | 0.024 sig |
| SECONDARY Median Daily Dose of Patiromer That Was Given in Treatment Arm |
8.4 | — |
| SECONDARY Number of Additional Hemodialysis Treatments Due to Hyperkalemia |
— | — |
| SECONDARY Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline |
4; 2; 2; 2; 2; 2 | — |
| SECONDARY Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Week 4 |
2; 4; 3; 2; 2; 1 | — |
| SECONDARY Number of Participants Who Completed All Study Visits |
16; 15 | — |
| SECONDARY Number of Participants With More Than 1000 Premature Ventricular Contractions (PVCs) in 24 Hours |
2; 4 | — |
| SECONDARY Change in Serum Albumin Concentration |
— | — |
| SECONDARY Change in Parathyroid Hormone (PTH) Concentration |
— | — |
| SECONDARY Change in Serum Potassium Concentration Two Weeks After Study Drug is Discontinued |
— | — |
| SECONDARY Change in Serum Phosphorus Concentration Two Weeks After Study Drug Has Been Discontinued |
— | — |
Eligibility Criteria
Inclusion Criteria
- Males and Females, age at least 18 years
- ESRD treated with thrice-weekly HD for ≥ 6 months.
- At least two measured pre-dialysis serum [K] ≥ 5.5 mEq/L or one [K] ≥ 6.0 mEq/L noted over the past three months
- Current use of dialysate with potassium concentration ≤ 2 mEq/L
- Typical consumption of at least two meals per day
- Have received customary dietary instruction over prior month
- Considered by the treating physician(s) to be in otherwise stable clinical condition.
- If patient is of childbearing potential, he/she will be willing to avoid pregnancy during the study using an acceptable birth control method.
Exclusion Criteria
- Not considered by the treating physician(s) to be adherent with recommended dialysis schedule and prescribed medications
- Life expectancy 10.5 mg/dL in prior three months
- Anticipated kidney transplant within the next 3 months
- Prisoners or others who are involuntarily incarcerated or detained
- Pregnant, breastfeeding, or considering pregnancy.
- Participation in a clinical trial of an experimental treatment within the past 30 days
Data sourced from ClinicalTrials.gov (NCT03781089) 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.