Evidence for Potassium Restriction in Hemodialysis (EvoKe-HD)

November 6, 2026 updated by: Amélie Bernier-Jean, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Evidence for Potassium Restriction in Hemodialysis (EvoKe-HD) Pilot Parallel Randomized Controlled Trial

EvoKe-HD is a pilot randomized controlled trial to assess the feasibility and potential for efficacy of a novel dietary approach to hyperkalemia. Contrary to the traditional recommendations limiting the intake of high-potassium whole foods, such as fruits and vegetables, the investigators propose to switch the focus to foods containing potassium that is readily absorbed by the body (high bioavailability), such as potassium from additives, processed meats, milk, fruit juices and sugary drinks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sixty adults receiving hemodialysis treatments with blood potassium levels ≥ 5.2 mmol/L on two occasions or more in the past three months will be randomly assigned to either the novel dietary counselling or the traditional approach. Both groups will meet with the renal dietician again once a month for 20 to 30 minutes, but the content of the recommendations will be different. The intervention and follow-up period will last three months. The investigators will record pre-dialysis potassium, bicarbonate, phosphorus, calcium and parathormone levels, blood pressure, volume status, hospitalizations, medication, and dialysis prescription changes monthly and assess nutritional status and satisfaction with food at the beginning and at the end of the study.

The study will be successful if 30% or more of the eligible patients agree to participate and complete the 3-month assessment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • CIUSSS du Nord-de-l'Île-de-Montréal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥18 years or older
  • Receiving hemodialysis 3 times/week for ≥ 3 months
  • Has at least two pre-dialysis serum potassium levels ≥5.2 mmol/L on any analysis in the past 3 months OR the most recent pre-dialysis serum potassium value ≥ 4.6 mmol/L and is currently prescribed a potassium-binding agent at a regular frequency (defined as ≥ once per week).
  • Can speak and understand French or English
  • Has not missed more than 1 dialysis session in the previous 3 months.
  • Is capable of providing informed consent.

Exclusion Criteria:

  • Is not expected to survive beyond 6 months
  • Does not control their dietary intake (e.g., residents of high-dependency nursing homes)
  • Significant cognitive impairment precluding understanding of the dietary recommendations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Restriction high bioavailability potassium sources

Participants will be asked to identify and avoid food items with potassium additives by revising the ingredient lists of the grocery products they consume. They will also be asked to reduce two sources of high bioavailability potassium, such as meat, milk, fruit juices, processed potatoes or coffee.
Behavioral: Novel dietary approach focused on restricting the intake of highly bioavailable potassium

Participants will be asked to identify and avoid food items with potassium additives by revising the ingredient lists of the grocery products they consume. They will also be asked to reduce two sources of high bioavailability potassium, such as meat, milk, fruit juices, processed potatoes or coffee.
Active Comparator: Control

Participants will be asked to reduce the intake of food items with high total potassium content. A list of moderate-to-high potassium food items will be provided to the participants.
Behavioral: Traditional approach

Participants will be asked to reduce the intake of food items with high total potassium content. A list of moderate-to-high potassium food items will be provided to the participants.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in average mid-week predialysis potassium level during the study period
Time Frame: 3 months
3 months
Percentage of prevalent dialysis patients recruited and retained for 3 months
Time Frame: 3 months

Primary feasibility outcome
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average monthly midweek pre-dialysis serum potassium level (mmol/L)
Time Frame: 3 months
3 months
Peak serum potassium over the study period
Time Frame: 3 months
3 months
Number of hyperkalemia (≥5.6 mmol/L) and severe hyperkalemia (>6 mmol/L) events
Time Frame: 3 months
3 months
Number of dialysis sessions with dialysate concentration < 2mmol/L
Time Frame: 3 months
3 months
Number of patients for whom the potassium dialysate concentration was raised or lowered (by ≥0.5mmol/L)
Time Frame: 3 months
3 months
Total dose of potassium binders (g) over the study period
Time Frame: 3 months
3 months
Number of participants taking potassium binders at 3 months
Time Frame: 3 months
3 months
Number of servings/day of high potassium bioavailability items (meat, dairy, juices, potatoes)
Time Frame: 3 months
3 months
Number of servings/day of moderate to high total potassium food items
Time Frame: 3 months
3 months
Ratio of plant to animal protein intake (g/g)
Time Frame: 3 months
3 months
Albumin levels (g/L)
Time Frame: 3 months
3 months
Body mass index (kg/m2)
Time Frame: 3 months
3 months
Change in weight (kg)
Time Frame: 3 months
3 months
Average monthly midweek pre-dialysis serum phosphate level (mmol/L)
Time Frame: 3 months
3 months
Average monthly midweek pre-dialysis serum calcium level (mmol/L)
Time Frame: 3 months
3 months
Pre-dialysis serum parathyroid hormone level (pmol/L)
Time Frame: 3 months
3 months
Monthly average serum bicarbonate levels (mmol/L)
Time Frame: 3 months
3 months
Inter-dialytic weight gain (kg/day)
Time Frame: 3 months
3 months
1-week average pre dialysis blood pressure (mmHg)
Time Frame: 3 months
3 months
Ratio of the number of randomized participants over the number of screened participants randomized
Time Frame: 3 months

Secondary feasibility outcome
3 months
Number of participants recruited 12 months into the trial
Time Frame: 3 months

Secondary feasibility outcome
3 months
Percentage of randomized participants who report having understood the dietary recommendations well or very well using a 1-7 Likert scale with anchors
Time Frame: 3 months

Secondary feasibility outcome
3 months
Percentage of randomized participants who judge the intervention to be acceptable using a 1-7 Likert scale with anchors
Time Frame: 3 months

Secondary feasibility outcome
3 months
Healthy diet index 2020
Time Frame: 3 months

Include 13 components that reflect the key recommendations in the Dietary Guidelines for Americans, 2020-2025. The maximum score is 100.
3 months
Mediterranean diet score
Time Frame: 3 months

0 to 100 score; higher score represents a better adherence to the Mediterranean diet
3 months
Mediterranean-diet scale
Time Frame: 3 months

Score from 0 (minimal adherence to the traditional Mediterranean diet) to 9 (maximal adherence)
3 months
Subjective global assessment
Time Frame: 3 months

Standardized subjective assessment of nutritional status performed by a dietitian. Final rating is either Well-nourished, Mildly/moderately malnourished or Severely malnourished with or without cachexia and/or sarcopenia.
3 months
Normalized protein nitrogen appearance (g/kg/day)
Time Frame: 3 months

calculated from urea reduction ratio
3 months
Satisfaction with food-related life
Time Frame: 3 months

5-item scale, total score range 0 to 100, higher score represents higher satisfaction with food
3 months
Self-perceived impact on diet
Time Frame: 3 months

"I changed my diet in the past 3 months based on the advice I received from the renal dietitian" (1-7 Likert scale with anchors)
3 months
Self-perceived compliance with the dietary recommendations
Time Frame: 3 months

"I am following the diet recommended by the renal dietitian" (1-7 Likert scale with anchors)
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 3 months
3 months
Major cardiovascular events
Time Frame: 3 months

Composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
3 months
Standardised Outcomes in NephroloGy fatigue measure
Time Frame: 3 months

3 questions answered on a 4-points Likert scale. The results of each question (rated 0 to 3) is summed up to obtain to total score (range 0 to 9)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-2643

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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