Potassium supplementation in patients with chronic kidney disease and healthy subjects: effects on potassium and sodium balance

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Patients:
•Adult patients (= 18 years) with CKD 3b or 4 (45 – 15 ml/min/1.73 m2).
•Hypertension (defined as office blood pressure > 140/90 mmHg and using RAAS inhibitor treatment).

Healthy subjects:
•Healthy adults (= 18 years), as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination (PE) and laboratory tests carried out in the screening visit (V0).
•Using no medication (excluding contraceptives).

Exclusion Criteria

Patients:
•Hyperkalemia (serum potassium > 5.5 mmol/l).
•Medical reasons to continue dual RAAS-blockade, mineralocorticoid receptor
blockers, potassium-sparing diuretics, or oral potassium binders.
•Patients with previous history of ventricular cardiac arrhythmia.
•Patients with diabetes mellitus.
•Patients with a life expectancy < 6 months.
•Expected initiation of renal replacement therapy < 6 months.
•Incapacitated subjects.
•Women who are pregnant, breastfeeding or consider pregnancy in the coming 6 months.

Healthy subjects:
•Hyperkalemia (serum potassium > 5.5 mmol/l).
•Women who are pregnant, breastfeeding or consider pregnancy in the coming 6 months.
•An office blood pressure = 140/90 mmHg.
•A body mass index = 30 kg/m2.
•A major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavourable for enrolment, including diabetes mellitus.
•A history of any type of malignancy within the past 5 years with the exception of successfully treated basal cell carcinoma of the skin.
•A history of any renal disease.
•A history of any blood clotting disorders.
•A history of any auto-immune disease.
•A history of cardiovascular disease (in the past 6 months) defined as documented coronary artery disease including myocardial infarction (MI), (un-)stable angina pectoris or acute coronary syndrome (ACS), percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG), cerebrovascular disease, including ischaemic and haemorrhagic stroke or a subarachnoid bleeding (SAB), or peripheral artery disease, including aortic aneurysmata (AA).
•A history of ventricular cardiac arrhythmia.
•Any significant sign or symptom of hypotension.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary study endpoint will be serum potassium (in mmol/L).

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints will include Red Blood Cell (RBC) potassium (in mmol/L), renal potassium excretion, serum sodium, renal sodium excretion, total body water, and systolic blood pressure, as well as changes in serum bicarbonate, insulin, and plasma aldosterone.

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