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Sodium zirconium cyclosilicate to allow liberal fruit and vegetable intake for patients with CKD stage 3b and 4 (LIBERAL study)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507823-52-00
Enrollment
16
Registered
2024-02-27
Start date
2024-05-27
Completion date
2025-03-12
Last updated
2024-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with chronic kidney disease stage 3b to 4

Brief summary

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.

Detailed description

Ambulatory blood pressure, 24 hours albuminuria, urinary potassium and sodium excretion, Plasma bicarbonate, Quality of life, using SF36 questionnaire, Effect on stool (assessed with Bristol Stool Chart), Difference in serum potassium one week after start of study (SCZ free period), Per protocol analysis of difference in serum potassium after six week (end of study), Incidence of severe hyperkalemia (serum potassium above 6.5 mmol/l or above 6.0 with ECG features of hyperkalemia)

Interventions

Sponsors

Academisch Ziekenhuis Leiden
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Ambulatory blood pressure, 24 hours albuminuria, urinary potassium and sodium excretion, Plasma bicarbonate, Quality of life, using SF36 questionnaire, Effect on stool (assessed with Bristol Stool Chart), Difference in serum potassium one week after start of study (SCZ free period), Per protocol analysis of difference in serum potassium after six week (end of study), Incidence of severe hyperkalemia (serum potassium above 6.5 mmol/l or above 6.0 with ECG features of hyperkalemia)

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026