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Active, Not Recruiting

NCT Number: NCT03253172

Potassium Supplementation in CKD

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Renal Insufficiency, Chronic Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperkalemia Hypertension Hypokalemia Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Potassium Depletion Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center Amsterdam, Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Potassium Chloride

Dietary Supplement

Two potassium supplements with varying anions.

Potassium citrate

Dietary Supplement

Potassium Citrate

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Difference in estimated glomerular filtration rate (eGFR)

    Time frame: Two years

Secondary outcomes

  1. ≥ 30% decrease in eGFR

    Time frame: Two years

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

    Time frame: Two years

  3. Doubling in serum creatinine or end-stage renal disease

    Time frame: Two years

  4. Progression to next CKD or albuminuria class

    Time frame: Two years

  5. Ambulatory (24-hour) blood pressure

    Time frame: Two years

  6. 24-hour albuminuria

    Time frame: Two years

  7. Cardiovascular event

    Time frame: 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

  8. All-cause mortality

    Time frame: Two years

  9. Incidence of hyperkalemia

    Time frame: Two years

  10. NT-pro-BNP

    Time frame: Two years

    Volume marker 1

  11. Bioimpedance measures

    Time frame: Two years

    Volume marker 2

  12. Pulse-wave velocity

    Time frame: Two years

    Cardiovascular marker 1

  13. High-sensitive CRP

    Time frame: Two years

    Cardiovascular marker 2

Other outcomes

  1. Effects of 2-week KCl supplementation on plasma potassium (mmol/l)

    Time frame: Two weeks

    Run-in outcome 1

  2. Incidence of Hyperkalemia after 2-week KCl supplementation

    Time frame: Two weeks

    Run-in outcome 2

  3. Effects of 2-week KCl supplementation on office blood pressure (mmHg)

    Time frame: Two weeks

    Run-in outcome 3

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Amsterdam UMC
  • Dutch Kidney Foundation
  • Leiden University Medical Center
  • University Medical Center Groningen

Registry information

Official study title

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

Acronym: K+ in CKD

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2017
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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