Chronic Kidney Disease and Hyperkalemia Treatment with Patiromer: The EMERALD Study – Phase II

Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer for Oral Suspension in Children and Adolescents 2 to < 18 Years of Age with Chronic Kidney Disease and Hyperkalemia

Protocol Description

Through this study, researchers are evaluating patiromer, also known by the trade name Veltassa®, for children who have chronic kidney disease and a high level of potassium in the blood, a condition called hyperkalemia. Patiromer binds potassium in the gastrointestinal tract to remove potassium from the body before it is absorbed into the bloodstream. It is approved for use in adults whose kidney disease impairs the filtering of waste products and potassium. This study will monitor the effects and effectiveness of patiromer in pediatric cases.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is accepting participants, ages 2 through 17, who have chronic kidney disease and hyperkalemia.
Boys and Girls: Ages 2 through 17

Requirements

After initial screening visits, researchers will follow a protocol with individual participants to determine their best dosage, which is taken daily as an oral solution. After this 2-week dose-finding period, participants will continue to take the study medicine over 5-1/2 months with up to 8 visits for examinations, including blood potassium monitoring. Up to 2 follow-up visits will be done after the dosing period ends.
Visits: Up to 14
Duration: About 6-1/2 months

Status: Open to Enrollment

Source(s) of Support

Relypsa

Primary Investigator

Michael Moritz, MD

Contact Information

For more information about the study or enrollment, please contact:
Vibha Chauhan, PhD, CCRP, CCRC
412-692-7924