LIBERAL Study
Key facts
- Where
- Leiden, HollandiaSee the site
- Phase
- 3. fázis
Where in Hollandia
- Leiden University Medical CenterLeiden, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Academisch Ziekenhuis Leiden
- Trial code
- EU 2023-507823-52-00
- Record updated
- 2024. november 28.
- Original description
To demonstrate that a potassium-rich diet, including the use of sodium zirconium cyclosilicate (SZC) as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassiumRead full original descriptionShow less
Sodium zirconium cyclosilicate to allow liberal fruit and vegetable intake for patients with CKD stage 3b and 4 (LIBERAL study)
To demonstrate that a potassium-rich diet, including the use of sodium zirconium cyclosilicate (SZC) as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium
Inclusion: Adult patients (≥ 18 years); Chronic kidney disease stage 3b to 4 (eGFR 44 – 15 ml/min/1.73 m2); Use of inhibitor of the renin-angiotensin system.
Exclusion: Kidney transplantation patients; Use of calcineurin inhibitors; Patients with a previous history of ventricular cardiac arrhythmia; Hyperkaliemia (plasma potassium > 5.5 mmol/L) at baseline or at the start of potassium enriched diet; Hypersensitivity to SCZ (Sodium zirconium cyclosilicate); 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; Patients with a prolonged QTc time on ECG; 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; Use of trimethoprim and sulfamethoxazole.