Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study

NACompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

November 3, 2020

Primary Completion Date

April 1, 2023

Study Completion Date

May 10, 2023

Conditions
Chronic Kidney Disease stage4Chronic Kidney Disease Stage 5Hyperkalemia
Interventions
COMBINATION_PRODUCT

sodium zirconium cyclosilicate and healthy diet

During 3 weeks, SZC will be prescribed to normalize plasma potassium to 3.5 to 5.0 mml/L, and a diet with energy 25-35 kcal/kg/day and protein 0.6 to 0.8 g/kg/day and with low K content will be prescribed. At the end of the first 3 weeks, the patients will initiate a healthy diet containing 3700 to 4000 mg/potassium for 3 weeks (healthy diet phase). A food basket containing fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the patient will be provided. Serum K will be monitored to promote serum K between 3.5 to 5.0 mmol/L and adjustments in the dose of SZC will be performed according to the drug label. During stabilization and healthy diet phases, serum K will be measured every 72 hours until serum K is normalized and after that, once per week.

Trial Locations (1)

14134

Karolinska Institutet, Stockholm

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Karolinska Institutet

OTHER