Potassium Supplementation in CKD

NCT03253172 — Not applicable, Active not recruiting, 532 participants, Erasmus Medical Center

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Renoprotective Effects of Potassium Supplementation in Chronic Kidney Disease (CKD)

Registry	NCT03253172, acronym K+ in CKD
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	532 (Estimated)
Sponsor	Erasmus Medical Center (Other); collaborators: Dutch Kidney Foundation, University Medical Center Groningen, Leiden University Medical Center, Amsterdam UMC
Conditions	Renal Insufficiency, Chronic, Potassium Depletion, Hypertension, Hyperkalemia
Interventions	Potassium Chloride, Potassium Citrate, Placebo (Dietary supplement)
Dates	start 2017-07-01, primary completion 2026-09-01 (estimated), completion 2026-10-01 (estimated), first posted 2017-08-17, last updated 2026-08-10
Locations	4 sites in Netherlands

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
Placebo	Placebo comparator	Dietary Supplement: Placebo	Placebo
Potassium Chloride	Experimental	Dietary Supplement: Potassium Chloride	Experimental Arm 1 - Rationale is that most evidence for a positive effect of potassium comes from studies using potassium chloride
Potassium Citrate	Experimental	Dietary Supplement: Potassium Citrate	Experimental Arm 2 - Rationale for citrate is that recent evidence indicates that alkali treatment may also be renoprotective.

Potassium Chloride (Dietary supplement): Two potassium supplements with varying anions.
Potassium Citrate (Dietary supplement): Potassium Citrate
Placebo (Dietary supplement): Placebo

+Outcome measures

Primary outcomes

Difference in estimated glomerular filtration rate (eGFR) [Two years]

Secondary outcomes

≥ 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 kidney failure (CKD stage 5 or start of kidney replacement therapy) [Two years]
Progression to next CKD or albuminuria class [Two years]
Ambulatory (24-hour) blood pressure [Two years]
Spot urine albumin to creatinine ratio (UACR) [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

Other outcomes

Effects of 2-week KCl supplementation on plasma potassium (mmol/l) [Two weeks]: Run-in outcome 1
Incidence of Hyperkalemia after 2-week KCl supplementation [Two weeks]: Run-in outcome 2
Effects of 2-week KCl supplementation on office blood pressure (mmHg) [Two weeks]: Run-in outcome 3

+Eligibility

Sex: All, ages: 18 Years to any

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)

Facility	City	Country
Academic Medical Center Amsterdam	Amsterdam	Netherlands
University Medical Center Groningen	Groningen	Netherlands
Leiden University Medical Center	Leiden	Netherlands
Erasmus MC	Rotterdam	Netherlands

+Publications

Results publication: Sunga CGG, Zelnick LR, Bansal N. Urinary Sodium and Potassium Excretion and the Risk of Cardiovascular Events in CKD. Kidney360. 2026 Jan 1;7(1):94-106. doi: 10.34067/KID.0000000943. Epub 2025 Aug 8. PMID 40779318
Results publication: 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. PMID 35609996

+Investigators

Ewout J Hoorn, MD, PhD, Principal investigator, Erasmus Medical Center

My Notes

Public

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