78
Participants
Start Date
September 30, 2022
Primary Completion Date
July 30, 2025
Study Completion Date
July 30, 2026
Sodium Zirconium Cyclosilicate
"The recommended starting dose of Lokelma is 10 g, administered three times a day.~If, at any time during the study, sK is \> 6.5 mEq/L, treatment for acute hyperkalemia will be started following common clinical practice and local protocols, and investigator will consider RAASi / MRA withdrawal, or downtitration. In this case (confirmed sK \> 6.5 mEq/L despite the maximum SZC dose) patient will leave the IP and will be counted as a treatment failure.~If sK is ≤ 3.0 mEq/L, discontinue SZC. The subject should immediately receive appropriate medical intervention.~If sK is between 3.1-5.1 mEq/L, pause SZC and re-evaluate in a week. This one-week SCZ treatment temporary discontinuation can only be applied once; if a new sK value between 3.1-5.1 mEq/L is detected, patient will leave the IP permanently.~Depending on the serum potassium levels at each visit, the dose of SZC will be adjusted."
RECRUITING
Hospital Universitario 12 de Octubre, Madrid
RECRUITING
Hospital Clínico Universitario de Valencia, Valencia
RECRUITING
Hospital Universitario Doctor Peset, Valencia
RECRUITING
Hospital General Universitario Dr. Balmis, Alicante
RECRUITING
Hospital Universitario Vall d'Hebrón, Barcelona
Fundación para la Investigación del Hospital Clínico de Valencia
OTHER