Potassium Supplementation in CKD
- Conditions
- Potassium DepletionRenal Insufficiency, ChronicHypertensionHyperkalemia
- Interventions
- Dietary Supplement: Potassium CitrateDietary Supplement: PlaceboDietary Supplement: Potassium Chloride
- Registration Number
- NCT03253172
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
The current high-sodium, low-potassium diet contributes to the high prevalence of high blood pressure (hypertension). Indeed, the anti-hypertensive effects of potassium supplementation are well-established. Hypertension is even more prevalent and resistant in patients with chronic kidney disease (CKD) and contributes to further decline in kidney function. Four recent epidemiological studies (published 2014 - 2016) showed that higher dietary potassium intake was associated with better renal outcomes. All studies recommended an intervention study with potassium supplementation in patients with CKD, but this has not been performed. The aim of this study is to study the renoprotective effect of potassium supplementation in patients with CKD (stage 3b or 4, i.e. estimated glomerular filtration rate \[eGFR\] 15 - 45 ml/min/1.73 m2).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 532
- CKD 3b or 4 (45 - 15 ml/min/1.73 m2)
- Δ eGFR (as estimated by the CKD-EPI equation) > 2 ml/min/1.73 m2/year (in preceding ≥ 1 year with at least 3 measurements)
- Hypertension (defined as office blood pressure > 140/90 mmHg or use of anti-hypertensive medication)
- Hyperkalemia (serum potassium > 5.5 mmol/l) at study visit V0
- 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 a life expectancy < 6 months
- Expected initiation of renal replacement therapy < 2 years
- Incapacitated subjects
- Women who are pregnant, breastfeeding or consider pregnancy in the coming 2 years.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Potassium Citrate Potassium Citrate Experimental Arm 2 - Rationale for citrate is that recent evidence indicates that alkali treatment may also be renoprotective. Placebo Placebo Placebo Potassium Chloride Potassium Chloride Experimental Arm 1 - Rationale is that most evidence for a positive effect of potassium comes from studies using potassium chloride
- Primary Outcome Measures
Name Time Method Difference in estimated glomerular filtration rate (eGFR) Two years
- Secondary Outcome Measures
Name Time Method Incidence of hyperkalemia Two years Slope analysis (change in eGFR in ml/min/1.73 m2/year) Two years All-cause mortality Two years Cardiovascular event Two years Coronary heart disease death, fatal myocardial infarction, fatal stroke and other cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, unstable angina, resuscitated cardiac arrest
NT-pro-BNP Two years Volume marker 1
Pulse-wave velocity Two years Cardiovascular marker 1
Bioimpedance measures Two years Volume marker 2
Doubling in serum creatinine or end-stage renal disease Two years Progression to next CKD or albuminuria class Two years Ambulatory (24-hour) blood pressure Two years ≥ 30% decrease in eGFR Two years 24-hour albuminuria Two years High-sensitive CRP Two years Cardiovascular marker 2
Trial Locations
- Locations (4)
Academic Medical Center Amsterdam
🇳🇱Amsterdam, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Erasmus MC
🇳🇱Rotterdam, Netherlands