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NCT07772856Not yet recruiting

Liberalizing Potassium Restrictions in Patients Receiving Hemodialysis

Evaluating the Safety and Acceptability of a Liberalized Potassium Diet in Maintenance Hemodialysis Recipients: A Randomized Controlled Trial (LIBERATE K-HD)

Source: ClinicalTrials.gov · Last updated 19 Aug 2026

Brief summary (registry, in English)

People with end-stage kidney disease who receive hemodialysis are often told to strictly limit foods high in potassium, such as fruits, vegetables, legumes, nuts, and whole grains. This advice is intended to prevent high blood potassium levels (hyperkalemia), which can cause dangerous heart rhythm problems. However, these restrictions can make eating difficult, reduce diet quality, and lower quality of life. New research suggests that not all sources of potassium affect the body in the same way. Potassium added to highly processed foods is more easily absorbed than potassium naturally found in whole foods like fruits and vegetables. Large studies have found little evidence that eating potassium-rich whole foods increases blood potassium levels in people on dialysis. Clinical guidelines are beginning to shift, but no high-quality clinical trial has tested whether a more flexible, food-based approach is safe for people receiving hemodialysis. This study will compare two dietary approaches in 148 adults on hemodialysis: the usual low potassium diet and a "liberalized" potassium diet that encourages minimally processed foods while limiting highly processed foods with potassium additives. Participants will receive dietitian support and grocery assistance for 12 weeks. The investigators will closely monitor blood potassium levels to ensure safety. The investigators will also examine whether the liberalized diet is as safe as standard care, and whether it improves diet quality and quality of life. The investigators will also study factors that influence the participant's ability to follow the diet in real-world settings. If safe, this approach could reduce unnecessary food restrictions, improve diet quality, and enhance quality of life for people receiving hemodialysis, while maintaining patient safety.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
148 (estimated)
First submitted
7 Aug 2026
Start date
1 Aug 2026
Primary completion date
1 Jul 2030
Lead sponsor
University of Ontario Institute of Technology
NCT number
NCT07772856

What you commit to

  • Study type: Interventional
  • Planned participants: 148
  • From 1 Aug 2026 to the primary completion date, 1 Jul 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • \>2 missed scheduled dialysis sessions in the previous month
  • Patients receiving \<3 hemodialysis sessions per week (ex/ incremental dialysis)

Other illness

  • Unable to comply with study procedures due to cognitive impairment, language barrier or for any additional reason specified by the attending clinician

Lab values

  • Treatment with potassium binders within the preceding 7 days
  • Average serum potassium concentration \>6.0 mmol/L over the past 3 months
  • HbA1c \>11%

Other

  • Average Urea reduction rate over the past 3 months \<65%
  • Swallowing difficulties or other GI issues preventing adequate intake
  • Residing in an institutional setting (e.g., Long-term care homes) where meals are provided

Who the study is looking for

  • Age ≥18 years on maintenance HD \>3 months
  • ≥1 serum potassium concentration \>5.0 mmol/L on routine bloodwork in past 12 months
  • Able to provide consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Michael's Hospital, Unity Health Toronto
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.