Using Sodium Zirconium Cyclosilicate to Increase Fruit and Vegetable Intake in Patients with Advanced Kidney Disease
Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4
This study tests if a medication can help people with advanced kidney disease eat more fruits and vegetables safely without raising their potassium levels.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, South-Holland) |
| Trial ID | NCT06365684 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of sodium zirconium cyclosilicate (SZC) to enable patients with chronic kidney disease (CKD) stage 3b and 4 to consume more fruits and vegetables without the risk of hyperkalemia. The study aims to demonstrate that SZC can effectively manage potassium levels, allowing for a diet rich in potassium from healthy food sources, which is often restricted in these patients. By promoting a more liberal intake of fruits and vegetables, the trial seeks to improve kidney outcomes and overall health in CKD patients. The study will include patients who are already on renin-angiotensin system inhibitors and will monitor their potassium levels throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with chronic kidney disease stage 3 to 4 who are currently using inhibitors of the renin-angiotensin system.
Not a fit: Patients with existing hyperkalemia or those on potassium binders will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve dietary options and health outcomes for patients with chronic kidney disease.
How similar studies have performed: Other studies have shown promising results with similar dietary interventions in CKD patients, but the specific use of SZC in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leiden, South-Holland
- Leiden University Medical Center — Leiden, South-Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Joris I Rotmans, Professor
- Email: j.i.rotmans@lumc.nl
- Phone: +31 71 5292148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.