NL-OMON48661RecruitingNot Applicable
Potassium supplementation in patients with chronic kidney disease and healthy subjects: effects on potassium and sodium balance - Acute K+ balance
Inwendige geneeskunde/Nefrologie0 sites50 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •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 single
- •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
- •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
- •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.
Investigators
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