Potassium Supplementation in CKD

N/AActive Not RecruitingNCT03253172

Erasmus Medical Center532 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

532

Conditions

Renal Insufficiency, Chronic Potassium Depletion Hypertension Hyperkalemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Academic Medical Center Amsterdam

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Erasmus MC

Rotterdam, Netherlands

Outcomes

Primary Outcomes

Difference in estimated glomerular filtration rate (eGFR)

Time frame: Two years

Secondary Outcomes

≥ 30% decrease in eGFR

Time frame: Two years

Slope analysis (change in eGFR in ml/min/1.73 m2/year)

Time frame: Two years

Doubling in serum creatinine or end-stage renal disease

Time frame: Two years

Progression to next CKD or albuminuria class

Time frame: Two years

Ambulatory (24-hour) blood pressure

Time frame: Two years

24-hour albuminuria

Time frame: Two years

Cardiovascular event

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

Time frame: Two years

All-cause mortality

Time frame: Two years

Incidence of hyperkalemia

Time frame: Two years

NT-pro-BNP

Volume marker 1

Time frame: Two years

Bioimpedance measures

Volume marker 2

Time frame: Two years

Pulse-wave velocity

Cardiovascular marker 1

Time frame: Two years

High-sensitive CRP

Cardiovascular marker 2

Time frame: Two years

Potassium Supplementation in CKD

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes