Potassium Supplementation in CKD

NCT ID: NCT03253172

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

532 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2026-10-01

Brief Summary

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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).

Detailed Description

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Conditions

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Renal Insufficiency, Chronic Potassium Depletion Hypertension Hyperkalemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Potassium Chloride

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

Group Type EXPERIMENTAL

Potassium Chloride

Intervention Type DIETARY_SUPPLEMENT

Two potassium supplements with varying anions.

Potassium Citrate

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

Group Type EXPERIMENTAL

Potassium Citrate

Intervention Type DIETARY_SUPPLEMENT

Potassium Citrate

Interventions

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Potassium Chloride

Two potassium supplements with varying anions.

Intervention Type DIETARY_SUPPLEMENT

Potassium Citrate

Potassium Citrate

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dutch Kidney Foundation

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role collaborator

Amsterdam UMC

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ewout Hoorn

Coordinating PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ewout J Hoorn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Academic Medical Center Amsterdam

Amsterdam, , Netherlands

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

Erasmus MC

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 35609996 (View on PubMed)

Other Identifiers

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MEC-2017-226

Identifier Type: OTHER

Identifier Source: secondary_id

CP16.01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL60825.078.17

Identifier Type: -

Identifier Source: org_study_id