Keeping RAASi Treatment With Optimal Potassium Control

PHASE3RecruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

September 30, 2022

Primary Completion Date

July 30, 2025

Study Completion Date

July 30, 2026

Conditions
Chronic Kidney Diseases
Interventions
DRUG

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."

Trial Locations (5)

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

46010

RECRUITING

Hospital Clínico Universitario de Valencia, Valencia

46017

RECRUITING

Hospital Universitario Doctor Peset, Valencia

03010

RECRUITING

Hospital General Universitario Dr. Balmis, Alicante

08035

RECRUITING

Hospital Universitario Vall d'Hebrón, Barcelona

All Listed Sponsors
lead

Fundación para la Investigación del Hospital Clínico de Valencia

OTHER