Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Apr 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether patients with chronic kidney disease (CKD) can safely eat more fruits and vegetables, which are high in potassium, by using a medication called sodium zirconium cyclosilicate (SZC). Normally, patients with CKD need to limit their potassium intake to avoid high potassium levels in the blood (a condition called hyperkalemia), but this trial aims to see if the use of SZC can help manage potassium levels while allowing a healthier diet. Participants will be randomly assigned to either continue their regular diet or add potassium-rich fruits and vegetables to their meals, with SZC used if needed to keep potassium levels stable.

To be eligible for the trial, participants should be adults aged 18 or older with CKD stage 3b to 4 and should be using a specific type of medication called a renin-angiotensin system inhibitor. However, those who already have high potassium levels or certain other health conditions will not be included. Throughout the study, participants can expect regular check-ins to measure their potassium levels and adjust their treatment as necessary. This trial is important because it could help CKD patients enjoy a healthier diet without the worry of harmful potassium levels.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Chronic Kidney disease, stage 3 to 4b (eGFR 44-15 ml/min/1.73m\^2)
• • Use of inhibitor of the renin-angiotensin system
• Exclusion Criteria:
• • Hyperkaliemia (plasma potassium \> 5.5 mmol/L) at baseline or at the start of potassium enriched diet
• • Use of potassium binders at baseline or at the start of potassium enriched diet
• • Use of dual RAAS-blockade, mineralocorticoid receptor blockers or potassium-sparing diuretics
• • Use of calcineurin inhibitors
• • Use of trimethoprim and sulfamethoxazole
• • Patients with a previous history of ventricular cardiac arrhythmia
• • Patients with a prolonged QTc time on ECG
• • Kidney transplantation patients
• • Patients with a life expectancy of \< 6 months
• • Incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team
• • Women who are pregnant, breastfeeding or considering pregnancy in the coming 6 months.
• • Hypersensitivity to SCZ