IBERAL Study

Phase 1

Recruiting

• Conditions: Patients with chronic kidney disease stage 3b to 4; MedDRA version: 21.1Level: LLTClassification code: 10081425Term: Arterial hypertension Class: 10047065; MedDRA version: 21.0Level: LLTClassification code: 10076411Term: Chronic kidney disease stage 4 Class: 10038359; MedDRA version: 21.1Level: PTClassification code: 10020646Term: Hyperkalaemia Class: 100000004861; MedDRA version: 21.0Level: LLTClassification code: 10076410Term: Chronic kidney disease stage 3 Class: 10038359; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2023-507823-52-00
• Lead Sponsor: Academisch Ziekenhuis Leiden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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 Criteria

Hyperkaliemia (plasma potassium > 5.5 mmol/L) at baseline or at the start of potassium enriched diet, 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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Objective: 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;Primary end point(s): 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 Outcome Measures

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