Table 1.

Patiromer titration schedule

Day 3		Weeks 1–3
Potassium level	≥5.5 mEq/L and > baseline	<3.8 mEq/L	3.8–5.0 mEq/L	>5.0–<5.5 mEq/L	≥5.5 mEq/L
Titration1	By 8.4 g/day	↓ By 8.4 g/day	No dose change	↑ By 8.4 g/day2	↑ By 8.4 g/day4
	Proceed to next weekly visit3	Proceed to next weekly visit3	Proceed to next weekly visit3	Proceed to next weekly visit3	Proceed to next weekly visit3

¹The daily dose of patiromer was increased or decreased by 8.4 g during the treatment period to maintain serum potassium (measured locally) within the target range of 3.8–5.0 mEq/L. At day 3 visit, patiromer dose should have been decreased to 0 for a confirmed potassium <3.8 mEq/L. If patiromer dose required titration, then initiation of the titrated dose occurred at the next planned administration.

²Dose titration was not required if the potassium decrease from the previous visit was ≥0.5 mEq/L.

³Additional safety visits were at the discretion of the investigator; upon request, patients returned for a safety visit <72 h. Mandatory safety visits were required if local potassium was >6.0 mEq/L. If the dose was already 25.2 g/day (maximum dose) and the patient had a confirmed potassium >6.0 mEq/L, standard of care for hyperkalemia was applied at the investigator's discretion.

⁴If the patiromer dose was already 25.2 g/day and the patient had a serum potassium ≥5.5 mEq/L, standard of care for hyperkalemia would be applied per the investigator's discretion and a safety visit may be scheduled within 72 h, also at the investigator's discretion.

The target serum potassium range was 3.8–5.0 mEq/L, and available doses for titration were: 0 g/day patiromer (no patiromer dispensed, minimum dose), 8.4 g/day, 16.8 g/day, 25.2 g/day (maximum dose). For all scheduled study visits (starting from day 3 and until the last visit before the end of treatment), titration instructions were identical between the with- and without-food treatment groups.