2023-507823-52-00CompletedPhase 3
LIBERAL Study
Sodium zirconium cyclosilicate to allow liberal fruit and vegetable intake for patients with CKD stage 3b and 4 (LIBERAL study)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 Nov 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 9 Nov 2023
- Start date
- 27 May 2024
- Lead sponsor
- Academisch Ziekenhuis Leiden
- Diseases
- Chronic kidney disease
- EU CT number
- 2023-507823-52-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 16
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Kidney transplantation patients
- Use of calcineurin inhibitors
- Patients with a previous history of ventricular cardiac arrhythmia
Lab values
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leiden University Medical Center | Leiden | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.