Abstract: INFO23

Design and Methods of an Open-Label, Multiple Dose Study of Patiromer in Pediatric Patients with CKD and Hyperkalemia (EMERALD)

Session Information

  • Informational Posters
    October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category:

Authors

  • Warady, Bradley A., Children's Mercy Kansas City, Kansas City, Missouri, United States
  • Gross, Coleman, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Mayo, Martha, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Ma, Jia, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Yllana, Joy, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Cui, Jin, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Schaefer, Franz S., University of Heidelberg, Heidelberg, BW, Germany
Description

To date, clinical trials of patiromer, a K+-binder approved for hyperkalemia (HK) treatment, have been performed solely in adults. Given its MOA, patiromer is expected to act similarly in adults and children with HK.
EMERALD (NCT03087058) is a Phase 2 open-label study evaluating the pharmacodynamics (PD), safety, and tolerability of patiromer for HK treatment in pediatric patients (pts). The study consists of an initial 14-day PD/dose-finding phase followed by a 5.5-month long-term treatment phase and a 14-day post-treatment follow-up phase (Figure). Eligible pts must be 2 to <18 yr (categorized by age cohorts [12–<18 yr, 6–<12 yr, and 2–<6 yr]) with eGFR <60 mL/min/1.73m2, including renal transplant and peritoneal dialysis pts, and have 2 blood K+ values 5.1–< 6.5 mEq/L on separate days. Screening/enrollment starts with the oldest age cohort; pts in the 2 younger age cohorts will not be enrolled until the prior age cohort has completed the initial treatment phase and the DSMC has given approval after evaluation of data from the prior cohort. Up to 3 starting doses will be evaluated in each age group, starting with the lowest planned dose. Patiromer will be titrated in age-appropriate dose increments to achieve a serum K+ (sK+) 3.8–5.0 mEq/L. The 1° efficacy endpoint is change in sK+ from baseline to Day 14. The secondary efficacy endpoints are % of pts with sK+ 3.8–5.0 mEq/L at Day 14 (dose finding) and by visit through Month 6 (long-term treatment); safety will be evaluated by adverse events, laboratory parameters, and vital signs.
Up to 54 pts will be enrolled (up to 18 per age cohort). The study is currently enrolling at >30 sites globally, including North America, Europe, and South Africa.
EMERALD is the first study to evaluate the use of patiromer in a pediatric cohort and will provide important data on dosing, safety and the K+ lowering effect of patiromer in children and adolescents with HK.

Funding

  • Relypsa, Inc., a Vifor Pharma Group Company