Clinical trial NCT03253172: Potassium Supplementation in CKD
Official title: Renoprotective Effects of Potassium Supplementation in Chronic Kidney Disease (CKD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Renal Insufficiency, Chronic
Potassium Depletion
Hypertension
Hyperkalemia
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Kidney Foundation
name: University Medical Center Groningen
name: Leiden University Medical Center
name: Amsterdam UMC
First posted: 2017-08-17
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in estimated glomerular filtration rate (eGFR)
timeFrame: Two years
Secondary outcomes:
measure: ≥ 30% decrease in eGFR
timeFrame: Two years
measure: Slope analysis (change in eGFR in ml/min/1.73 m2/year)
timeFrame: Two years
measure: Doubling in serum creatinine or end-stage renal disease
timeFrame: Two years
measure: Progression to next CKD or albuminuria class
timeFrame: Two years
measure: Ambulatory (24-hour) blood pressure
timeFrame: Two years
measure: 24-hour albuminuria
timeFrame: Two years
measure: Cardiovascular event
timeFrame: Two years
measure: All-cause mortality
timeFrame: Two years
measure: Incidence of hyperkalemia
timeFrame: Two years
measure: NT-pro-BNP
timeFrame: Two years
measure: Bioimpedance measures
timeFrame: Two years
measure: Pulse-wave velocity
timeFrame: Two years
measure: High-sensitive CRP
timeFrame: Two years
Other outcomes:
measure: Effects of 2-week KCl supplementation on plasma potassium (mmol/l)
timeFrame: Two weeks
measure: Incidence of Hyperkalemia after 2-week KCl supplementation
timeFrame: Two weeks
measure: Effects of 2-week KCl supplementation on office blood pressure (mmHg)
timeFrame: Two weeks
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center Amsterdam
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Ewout J Hoorn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gritter M, Wouda RD, Yeung SMH, Wieers MLA, Geurts F, de Ridder MAJ, Ramakers CRB, Vogt L, de Borst MH, Rotmans JI, Hoorn EJ; on behalf of K onsortium. Effects of Short-Term Potassium Chloride Supplementation in Patients with CKD. J Am Soc Nephrol. 2022 Sep;33(9):1779-1789. doi: 10.1681/ASN.2022020147. Epub 2022 May 24.