protocolSection identificationModule nctId: NCT06365684, orgStudyIdInfo id: 133548, secondaryIdInfos id: 2023-507823-52, type: EUDRACT_NUMBER, briefTitle: Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4, acronym: LIBRAL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, collaborators name: AstraZeneca, descriptionModule briefSummary: Rationale: Several studies have shown that higher urinary potassium excretion (as proxy for potassium intake) is associated with better kidney outcomes, lower blood pressure and improved survival. These associations are also observed in patients with (advanced) CKD. However, application in daily practice in patients with CKD, is impaired by the risk of hyperkalemia, due to metabolic acidosis and impaired renal potassium excretion in these patients. As a consequence, patients with CKD are advised to restrict their intake of fruit and vegetables, as these healthy food components are important sources of dietary potassium. This is particularly undesirable for patients with CKD in view of the very high risk of cardiovascular disease.Concomitant use of sodium zirconium cyclosilicate (SZC) could allow a more liberal intake of fruit and vegetables for patients with CKD, as SZC effectively treats hyperkalemia and counteracts metabolic acidosis \[1\]. With this strategy, the beneficial effects of potassium in fruits and vegetables on (vascular) health could also become accessible to patients with CKD.Objective: To demonstrate that a potassium-rich diet, including the use of SZC as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium (i.e. max rise of 0.5 mmol/L and no hyperkalemia). Study Design: Investigator initiated, single center, cross-over randomized clinical trial with non-inferiority design (14 weeks, 2 groups: regular diets vs. diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary) Study population: Outpatients ( age ≥ 18 years ) with chronic kidney disease stage IIIb/IV and use of inhibitor of the renin-angiotensin system (RASi).Intervention: Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet. Addition of SZC after 1 week in case hyperkaliemia develops (serum potassium \&gt; 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed, conditionsModule conditions: Hyperkalemia, conditions: Diet Modification, conditions: Chronic Kidney Disease, conditions: Sodium Zirconium Cyclosilicate, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Single center, cross-over randomized clinical trial with non-inferiority design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Sodium zirconium cyclosilicate, outcomesModule primaryOutcomes measure: The difference of serum potassium at baseline and after six weeks of treatment with potassium enriched diet (non-inferiority design) compared to the control group. With an intention to treat analysis., secondaryOutcomes measure: Ambulatory blood pressure (average systolic and diastolic blood pressure over 24 hours), secondaryOutcomes measure: 24 hours albuminuria, secondaryOutcomes measure: urinary potassium (mmol/l), secondaryOutcomes measure: Plasma bicarbonate, secondaryOutcomes measure: Quality of life, using SF36 questionnaire, secondaryOutcomes measure: Effect on stool (assessed with Bristol Stool Chart), secondaryOutcomes measure: Difference in serum potassium one week after start of study (SCZ free period), secondaryOutcomes measure: Per protocol analysis of difference in serum potassium after six week (end of study), secondaryOutcomes measure: Incidence of severe hyperkalemia (serum potassium above 6.5 mmol/l or above 6.0 with ECG features of hyperkalemia), secondaryOutcomes measure: Incidence of hyperkalemia (serum potassium above 5.5 mmol/l), secondaryOutcomes measure: Necessity for treatment of hyperkalemia, secondaryOutcomes measure: urinary sodium (mmol/l), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False