Hyperkalemia, Diminished Renal ExcretionEvoKe-HDNCT06120608
Evidence for Potassium Restriction in Hemodialysis
A study testing Novel dietary approach focused on restricting the intake of highly bioavailable potassium and Traditional approach in people with Hyperkalemia, Diminished Renal Excretion, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia, Diminished Renal Excretion
- What is being tested?
- Novel dietary approach focused on restricting the intake of highly bioavailable potassium and Traditional approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jun 2025to 12 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperkalemia, Diminished Renal Excretion
- Being tested
- Novel dietary approach focused on restricting the intake of highly bioavailable potassium, Traditional approach
- Keywords
- Potassium, Hyperkalemia, Hemodialysis, Nutrition
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel dietary approach focused on restricting the intake of highly bioavailable potassiumBehavioural
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.
Traditional approachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Restriction high bioavailability potassium sources | Experimental | 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. Receives: Behavioral: Novel dietary approach focused on restricting the intake of highly bioavailable potassium |
| Control | Active comparator | 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. Receives: Behavioral: Traditional approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of prevalent dialysis patients recruited and retained for 3 months
Primary feasibility outcome
Measured: 3 months
Change in average mid-week predialysis potassium level during the study period
Measured: 3 months
Secondary outcomes (31)
Ratio of the number of randomized participants over the number of screened participants randomized
Secondary feasibility outcome
Measured: 3 months
Number of participants recruited 12 months into the trial
Secondary feasibility outcome
Measured: 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
Secondary feasibility outcome
Measured: 3 months
Percentage of randomized participants who judge the intervention to be acceptable using a 1-7 Likert scale with anchors
Secondary feasibility outcome
Measured: 3 months
Average monthly midweek pre-dialysis serum potassium level (mmol/L)
Measured: 3 months
Peak serum potassium over the study period
Measured: 3 months
Number of hyperkalemia (≥5.6 mmol/L) and severe hyperkalemia (>6 mmol/L) events
Measured: 3 months
Number of dialysis sessions with dialysate concentration < 2mmol/L
Measured: 3 months
Number of patients for whom the potassium dialysate concentration was raised or lowered (by ≥0.5mmol/L)
Measured: 3 months
Total dose of potassium binders (g) over the study period
Measured: 3 months
Number of participants taking potassium binders at 3 months
Measured: 3 months
Healthy diet index 2020
Include 13 components that reflect the key recommendations in the Dietary Guidelines for Americans, 2020-2025. The maximum score is 100.
Measured: 3 months
Mediterranean diet score
0 to 100 score; higher score represents a better adherence to the Mediterranean diet
Measured: 3 months
Mediterranean-diet scale
Score from 0 (minimal adherence to the traditional Mediterranean diet) to 9 (maximal adherence)
Measured: 3 months
Number of servings/day of high potassium bioavailability items (meat, dairy, juices, potatoes)
Measured: 3 months
Number of servings/day of moderate to high total potassium food items
Measured: 3 months
Ratio of plant to animal protein intake (g/g)
Measured: 3 months
Subjective global assessment
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.
Measured: 3 months
Albumin levels (g/L)
Measured: 3 months
Normalized protein nitrogen appearance (g/kg/day)
calculated from urea reduction ratio
Measured: 3 months
Body mass index (kg/m2)
Measured: 3 months
Change in weight (kg)
Measured: 3 months
Satisfaction with food-related life
5-item scale, total score range 0 to 100, higher score represents higher satisfaction with food
Measured: 3 months
Self-perceived impact on diet
"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)
Measured: 3 months
Self-perceived compliance with the dietary recommendations
"I am following the diet recommended by the renal dietitian" (1-7 Likert scale with anchors)
Measured: 3 months
Average monthly midweek pre-dialysis serum phosphate level (mmol/L)
Measured: 3 months
Average monthly midweek pre-dialysis serum calcium level (mmol/L)
Measured: 3 months
Pre-dialysis serum parathyroid hormone level (pmol/L)
Measured: 3 months
Monthly average serum bicarbonate levels (mmol/L)
Measured: 3 months
Inter-dialytic weight gain (kg/day)
Measured: 3 months
1-week average pre dialysis blood pressure (mmHg)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start17 Jun 2025
- Primary completion12 Mar 2026 (estimated)
- Study completion12 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperkalemia, Diminished Renal ExcretionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Amélie Bernier-Jean, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120608
- Sponsor's protocol ID
- 2024-2643
- Acronym
- EvoKe-HD
- Status last verified
- Dec 2025
- First submitted
- 18 Oct 2023
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence for Potassium Restriction in Hemodialysis (EvoKe-HD) Pilot Parallel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06120608
- Acronym / sponsor ID
- EvoKe-HD / 2024-2643
- Conditions
- Hyperkalemia, Diminished Renal Excretion
- Keywords
- Potassium, Hyperkalemia, Hemodialysis, Nutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 12 Mar 2026 (estimated)
- Study completion
- 12 Mar 2026 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restriction high bioavailability potassium sources | Experimental | Behavioral: Novel dietary approach focused on restricting the intake of highly bioavailable potassiumParticipants 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. |
| Control | Active comparator | Behavioral: Traditional approachParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel dietary approach focused on restricting the intake of highly bioavailable potassiumParticipants 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. | Behavioural | Restriction high bioavailability potassium sources |
| Traditional approachParticipants 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. | Behavioural | Control |
Primary outcome
Percentage of prevalent dialysis patients recruited and retained for 3 months
Time frame: 3 months
Primary feasibility outcome
Change in average mid-week predialysis potassium level during the study period
Time frame: 3 months
31 secondary outcomes
Ratio of the number of randomized participants over the number of screened participants randomized
Time frame: 3 months
Number of participants recruited 12 months into the trial
Time frame: 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
Percentage of randomized participants who judge the intervention to be acceptable using a 1-7 Likert scale with anchors
Time frame: 3 months
Average monthly midweek pre-dialysis serum potassium level (mmol/L)
Time frame: 3 months
Peak serum potassium over the study period
Time frame: 3 months
Number of hyperkalemia (≥5.6 mmol/L) and severe hyperkalemia (>6 mmol/L) events
Time frame: 3 months
Number of dialysis sessions with dialysate concentration < 2mmol/L
Time frame: 3 months
Number of patients for whom the potassium dialysate concentration was raised or lowered (by ≥0.5mmol/L)
Time frame: 3 months
Total dose of potassium binders (g) over the study period
Time frame: 3 months
Number of participants taking potassium binders at 3 months
Time frame: 3 months
Healthy diet index 2020
Time frame: 3 months
Mediterranean diet score
Time frame: 3 months
Mediterranean-diet scale
Time frame: 3 months
Number of servings/day of high potassium bioavailability items (meat, dairy, juices, potatoes)
Time frame: 3 months
Number of servings/day of moderate to high total potassium food items
Time frame: 3 months
Ratio of plant to animal protein intake (g/g)
Time frame: 3 months
Subjective global assessment
Time frame: 3 months
Albumin levels (g/L)
Time frame: 3 months
Normalized protein nitrogen appearance (g/kg/day)
Time frame: 3 months
Body mass index (kg/m2)
Time frame: 3 months
Change in weight (kg)
Time frame: 3 months
Satisfaction with food-related life
Time frame: 3 months
Self-perceived impact on diet
Time frame: 3 months
Self-perceived compliance with the dietary recommendations
Time frame: 3 months
Average monthly midweek pre-dialysis serum phosphate level (mmol/L)
Time frame: 3 months
Average monthly midweek pre-dialysis serum calcium level (mmol/L)
Time frame: 3 months
Pre-dialysis serum parathyroid hormone level (pmol/L)
Time frame: 3 months
Monthly average serum bicarbonate levels (mmol/L)
Time frame: 3 months
Inter-dialytic weight gain (kg/day)
Time frame: 3 months
1-week average pre dialysis blood pressure (mmHg)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel dietary approach focused on restricting the intake of highly bioavailable potassium and Traditional approach in people with Hyperkalemia, Diminished Renal Excretion, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of prevalent dialysis patients recruited and retained for 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.