Potassium Supplementation in CKD (K+ in CKD)

Erasmus University

Status: Active, not recruiting

Conditions: Hyperkalemia; Hypertension; Potassium Depletion; Renal Insufficiency, Chronic

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Potassium Chloride; Dietary Supplement: Potassium Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03253172

MEC-2017-226 (Other Identifier)

NL60825.078.17

CP16.01 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment: 532 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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532 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo

Potassium Chloride

Experimental group

Description:

Experimental Arm 1 - Rationale is that most evidence for a positive effect of potassium comes from studies using potassium chloride

Treatment:

Dietary Supplement: Potassium Chloride

Potassium Citrate

Experimental group

Description:

Experimental Arm 2 - Rationale for citrate is that recent evidence indicates that alkali treatment may also be renoprotective.

Treatment:

Dietary Supplement: Potassium Citrate