Potassium Supplementation in CKD

Hypertension Clinical Trial

— K+ in CKD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03253172
• Other study ID #: NL60825.078.17
• Secondary ID: MEC-2017-226CP16
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: October 1, 2025

Study information

• Verified date: January 2022
• Source: Erasmus Medical Center
• Contact: Ewout J Hoorn, MD, PhD
• Phone: +31107040704
• Email: e.j.hoorn[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 532
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CKD 3b or 4 (45 - 15 ml/min/1.73 m2)

• ? 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.

Related Conditions & MeSH terms

• Hyperkalemia
• Hypertension
• Hypokalemia
• Potassium Depletion
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Potassium Chloride
Two potassium supplements with varying anions.
• Potassium Citrate
Potassium Citrate
• Placebo
Placebo

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Erasmus Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Dutch Kidney Foundation, Leiden University Medical Center, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effects of 2-week KCl supplementation on plasma potassium (mmol/l)	Run-in outcome 1	Two weeks
Other	Incidence of Hyperkalemia after 2-week KCl supplementation	Run-in outcome 2	Two weeks
Other	Effects of 2-week KCl supplementation on office blood pressure (mmHg)	Run-in outcome 3	Two weeks
Primary	Difference in estimated glomerular filtration rate (eGFR)		Two years
Secondary	= 30% decrease in eGFR		Two years
Secondary	Slope analysis (change in eGFR in ml/min/1.73 m2/year)		Two years
Secondary	Doubling in serum creatinine or end-stage renal disease		Two years
Secondary	Progression to next CKD or albuminuria class		Two years
Secondary	Ambulatory (24-hour) blood pressure		Two years
Secondary	24-hour albuminuria		Two years
Secondary	Cardiovascular event	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	Two years
Secondary	All-cause mortality		Two years
Secondary	Incidence of hyperkalemia		Two years
Secondary	NT-pro-BNP	Volume marker 1	Two years
Secondary	Bioimpedance measures	Volume marker 2	Two years
Secondary	Pulse-wave velocity	Cardiovascular marker 1	Two years
Secondary	High-sensitive CRP	Cardiovascular marker 2	Two years