WASHINGTON—Patiromer is safe for treating hyperkalemia in adolescent children with chronic kidney disease (CKD), according to preliminary data from an ongoing clinical trial presented at the American Society of Nephrology’s Kidney Week 2019 meeting.
The sodium-free potassium binder is well tolerated and results in clinically meaningful declines in serum potassium, according to investigators. Patiromer is approved for treating hyperkalemia in adults, but for use in children.
Bradley A. Warady, MD, of Children’s Mercy Kansas City, in Kansas City, Missouri, and colleagues examined the drug’s pharmacodynamics and safety in EMERALD, an open-label trial that enrolled children younger than 18 years but older than 2 years, with no study participants on hemodialysis. The trial consists of a 14-day dose-finding pharmacodynamics phase and a 5.5-month long-term treatment phase. The primary end point is the change in serum potassium baseline to day 14. Up to 54 patients will be enrolled in 3 sequential cohorts based on age.
The investigators presented findings from 14 patients at least 12 years fold but younger than 18 years (mean age 14.5 years). The patients had a mean baseline serum potassium level of 5.54 mEq/L and mean estimated glomerular filtration rate of 28.7 mL/min/1.73 m2. More than half of the patients were on renin-angiotensin-aldosterone system inhibitors.
All patients completed the pharmacodynamics phase of the trial. The starting dose was 4.2 g/day for all patients, and 8.4 g/day was the most common final prescribed dose (33% of patients) at the end of the study. Serum potassium declined by 0.50 mEq/L at day 14 and by 1.08 mEq/L at week 26. In addition, 50% and 82% of patients achieved target serum potassium levels by day 14 and 26, respectively. Dr Warady’s team observed adverse events in 71% of patients; these were mostly mild or moderate in severity. The most common class of AEs was gastrointestinal disorders (diarrhea, flatulence, nausea). Three patients had AEs considered related to the study drug. No AEs resulted in discontinuation of the study drug.
Warady BA, Gross C, Mayo M, et al. Patiromer treatment of hyperkalemia in adolescent children with CKD: Initial results from EMERALD. Presented at the American Society of Nephrology’s Kidney Week 2019 meeting held November 5 to 10 in Washington, DC. Poster TH-PO764