Potassium Supplementation in CKD

NCT03253172 | Active Not Recruiting DMC

• 3 other identifiers: NL60825.078.17MEC-2017-226CP16.01
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 4

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).

Conditions

Renal Insufficiency, Chronic; Potassium Depletion; Hypertension; Hyperkalemia

Outcome Measures

Primary Outcomes (1)

• Difference in estimated glomerular filtration rate (eGFR)

  Two years

Secondary Outcomes (13)

• ≥ 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 end-stage renal disease

  Two years

• Progression to next CKD or albuminuria class

  Two years

• Ambulatory (24-hour) blood pressure

  Two years

Other Outcomes (3)

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

  Two weeks

• Incidence of Hyperkalemia after 2-week KCl supplementation

  Two weeks

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

  Two weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Potassium Chloride

EXPERIMENTAL

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

Dietary Supplement: Potassium Chloride

Potassium Citrate

EXPERIMENTAL

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

Dietary Supplement: Potassium Citrate

Interventions

Potassium Chloride DIETARY_SUPPLEMENT

Two potassium supplements with varying anions.

Potassium Chloride

Potassium Citrate DIETARY_SUPPLEMENT

Potassium Citrate

Potassium Citrate

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Dutch Kidney Foundation: collaborator
• University Medical Center Groningen: collaborator
• Leiden University Medical Center: collaborator
• Amsterdam UMC: collaborator

Study Sites (4)

Academic Medical Center Amsterdam

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypokalemia; Hypertension; Hyperkalemia

Interventions

Potassium Chloride; Potassium Citrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Potassium Compounds; Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ewout J Hoorn, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating PI

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 17, 2017
• Study Start: July 1, 2017
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

NL (4)