Renal Insufficiency, Chronic, Potassium Depletion, Hypertension, Hyperkalemia
Conditions
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).
Interventions
DIETARY_SUPPLEMENTPotassium Chloride
Two potassium supplements with varying anions.
DIETARY_SUPPLEMENTPotassium Citrate
Potassium Citrate
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Erasmus Medical Center
Dutch Kidney Foundation
University Medical Center Groningen
Leiden University Medical Center
Amsterdam UMC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in estimated glomerular filtration rate (eGFR) | Two years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ≥ 30% decrease in eGFR | Two years | — |
| Slope analysis (change in eGFR in ml/min/1.73 m2/year) | Two years | — |
| 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 | — |
| 24-hour albuminuria | 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 |
| All-cause mortality | Two years | — |
| Incidence of hyperkalemia | Two years | — |
| NT-pro-BNP | Two years | Volume marker 1 |
| Bioimpedance measures | Two years | Volume marker 2 |
| Pulse-wave velocity | Two years | Cardiovascular marker 1 |
| High-sensitive CRP | Two years | Cardiovascular marker 2 |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATOREwout J Hoorn, MD, PhD
Erasmus Medical Center
Outcome results
None listed