Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
Hyperkalemia, End Stage Renal Disease
About this trial
This is an interventional prevention trial for Hyperkalemia focused on measuring Hemodialysis
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 < 3 months
- Dialysis-dependent for less than 6 months
- Non-elective hospitalization in prior 3 months
- Currently prescription of oral potassium supplements
- In the prior 3 months, therapy with oral potassium-lowering medication
- Underlying severe gastrointestinal disorders, including history of ischemic bowel.
- Corrected serum calcium concentration > 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
Sites / Locations
- DaVita Dialysis Sites
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Patiromer Oral Powder Product
Usual care arm
Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L.
Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol