LIBERAL Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Academisch Ziekenhuis Leiden

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

27 May 2024 → 12 Mar 2025

Decision date (initial)

2024-02-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

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

Secondary objectives 1

1. To investigate the effect of a potassium-containing diet, if necessary in combination with SZC on acid-base balance, blood pressure, albuminuria and quality of life

Conditions and MedDRA coding

Patients with chronic kidney disease stage 3b to 4

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Adult patients (≥ 18 years)
2. Chronic kidney disease stage 3b to 4 (eGFR 44 – 15 ml/min/1.73 m2)
3. Use of inhibitor of the renin-angiotensin system

Exclusion criteria 12

1. Hyperkaliemia (plasma potassium > 5.5 mmol/L) at baseline or at the start of potassium enriched diet
2. Incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team
3. Women who are pregnant, breastfeeding or considering pregnancy in the coming 6 months
4. Use of potassium binders at baseline or at the start of potassium enriched diet
5. Use of dual RAAS-blockade, mineralocorticoid receptor blockers or potassium-sparing diuretics
6. Use of calcineurin inhibitors
7. Use of trimethoprim and sulfamethoxazole
8. Patients with a previous history of ventricular cardiac arrhythmia
9. Patients with a prolonged QTc time on ECG
10. Kidney transplantation patients
11. Patients with a life expectancy of < 6 months
12. Hypersensitivity to SCZ (Sodium zirconium cyclosilicate)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 9

1. Ambulatory blood pressure
2. 24 hours albuminuria
3. urinary potassium and sodium excretion
4. Plasma bicarbonate
5. Quality of life, using SF36 questionnaire
6. Effect on stool (assessed with Bristol Stool Chart)
7. Difference in serum potassium one week after start of study (SCZ free period)
8. Per protocol analysis of difference in serum potassium after six week (end of study)
9. Incidence of severe hyperkalemia (serum potassium above 6.5 mmol/l or above 6.0 with ECG features of hyperkalemia)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Academisch Ziekenhuis Leiden

Sponsor organisation

Academisch Ziekenhuis Leiden

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

W.T. Moest

Public contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

Clinical research unit interne geneeskunde

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications