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

NCT ID: NCT06365684

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2025-05-01

Brief Summary

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 > 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed

Conditions

Hyperkalemia; Diet Modification; Chronic Kidney Disease; Sodium Zirconium Cyclosilicate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Potassium enriched diet

Patients with chronic kidney disease stage 3b to 4 will be treated for 6 weeks with a potassium enriched diet (adding +40mmol/day in the form of fruits/vegetables/nuts)

Group Type: EXPERIMENTAL

Sodium zirconium cyclosilicate

Intervention Type: DRUG

In the case of hyperkalemia patients will be treated with Sodium zirconium cyclosilicate to allow the continuation of potassium enriched diet. In case hyperkalemia arises in the control group, patients will be treated with Sodium zirconium cyclosilicate as well.

Regular diet

Patients with chronic kidney disease stage 3b to 4 will followed for 6 weeks, during their regular diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sodium zirconium cyclosilicate

In the case of hyperkalemia patients will be treated with Sodium zirconium cyclosilicate to allow the continuation of potassium enriched diet. In case hyperkalemia arises in the control group, patients will be treated with Sodium zirconium cyclosilicate as well.

Intervention Type: DRUG

Other Intervention Names

Lokelma

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

JorisRotmans

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Joris I Rotmans, Professor

Role: CONTACT

j.i.rotmans@lumc.nl

+31 71 5292148

Wouter T Moest, MD

Role: CONTACT

w.t.moest@lumc.nl

+31 71 5292148

Facility Contacts

Joris I. Rotmans, professor

Role: primary

j.i.rotmans@lumc.nl

+31 71 5262148

Wouter Moest, MD

Role: backup

w.t.moest@lumc.nl

+31 71 5262148

Other Identifiers

2023-507823-52

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

133548

Identifier Type: -

Identifier Source: org_study_id