AzTrials
AzTrials

HemodialysisDLITENCT07738731

Dialysis Less Frequently in the Elderly

A study testing Twice weekly hemodialysis and Thrice weekly hemodialysis treatment in people with Hemodialysis and End Stage Kidney Disease (ESKD), run by Queen's University at 11 sites in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Many people who have kidney failure require hemodialysis treatments to stay alive. Hemodialysis is a procedure that cleans the blood of the toxins and fluids that build up when kidneys don't work. Most patients receive hemodialysis treatment three times every week and each treatment lasts 4 hours. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Hemodialysis, End Stage Kidney Disease (ESKD)
What is being tested?
Twice weekly hemodialysis and Thrice weekly hemodialysis treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
11 sitesCanada
Study dates
Oct 2026to Oct 2031
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • patients aged 70 or above
  • have developed end stage kidney disease and require hemodialysis treatment

Who cannot join

  • Hospitalized patients without an alternate level of care designation
  • Those with missed hemodialysis sessions due to non-adherence during the first 7 weeks of hemodialysis treatment
  • Patients already prescribed twice weekly hemodialysis
  • Patients who are medically unsuitable as per primary care team and site investigator
  • anticipated significant barriers to ascertainment of patient-reported experience measures

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Christine A White, MD contact

613-533-3134

cw38@queensu.ca

11 sites in 1 country

Canada11 sites

  • Dalhousie University

    Halifax, Nova Scotia

    Karthik Tenankore

  • Queen's University

    Kingston, Ontario, K7L 4B7

    Christine A White, MD, 613-533-3134, cw38@queensu.ca

    Rachel M Holden, MD, 613-533-3134, rachel.holden@kingstonhsc.ca

  • CHUM

    Montreal, Quebec

    Isabelle Ethier

  • Hopital du Sacre-Coeur-de-Montreal

    Montreal, Quebec

    Remi Goupil

  • Hopital du Sacre-Coeur-de-Montreal

    Montreal, Quebec

    Josée Bouchard

  • Hopital Maisoneuve-Rosemont

    Montreal, Quebec

    Annie Claire Nadeau-Fredette

  • Hôpital du Haut-Richelieu

    Montreal, Quebec

    Mona Ben M'Rad

  • McGill University

    Montreal, Quebec

    Rita Suri

  • Centre de Recherche du CHU de Quebec: Laval University

    Québec, Quebec

    Fabrice Mac-Way

  • Memorial University

    St. John's, Newfoundland and Labrador

    Pamela Pike

  • Multiple Sites

    Vancouver, British Columbia

    Shao Yao

Other trials in Canada

About this study

Official title: A Randomized Controlled Study of Dialysis Less Frequently in the Elderly

Many people who have kidney failure require hemodialysis treatments to stay alive. Hemodialysis is a procedure that cleans the blood of the toxins and fluids that build up when kidneys don't work. Most patients receive hemodialysis treatment three times every week and each treatment lasts 4 hours. These patients spend 156 days per year receiving hemodialysis treatments. This is a very large time burden which has a tremendous impact on well-being and life satisfaction. Current usual approach of prescribing three hemodialysis treatments per week is not based on good studies and assumes that all people need the same number of hemodialysis treatments per week regardless of their age, values, life expectancy or other health conditions. Over time, increasingly more elderly people are needing to start hemodialysis treatments. The investigators have conducted a preliminary study that shows that patients who are 70 years of age or older can do well when only receiving only two hemodialysis treatments per week. In this preliminary study, receiving two hemodialysis treatments per week was no different than three hemodialysis treatments per week with regards to important safety measures including blood values and management of body fluid levels. The investigators now propose to carry out a much larger study in many centers across Canada that will compare two times per week hemodialysis treatments to three times per week hemodialysis treatments in elderly patients who have reached kidney failure and are beginning their hemodialysis journey. The investigators want to know if receiving hemodialysis treatments twice per week increases the number of days that a patient is able to spend at home without increasing rates of hospitalization or death compared to receiving hemodialysis treatments three times per week. The investigators also want to know if this is better for people's quality of life, safe, less expensive for the health care system and friendlier to the environment. The results of this study will help elderly patients needing to start hemodialysis treatments, medical care teams who help make decisions about how many hemodialysis treatments per week are necessary as well as kidney organizations that oversee kidney care for patients in Canada and around the world.

Being tested
Twice weekly hemodialysis, Thrice weekly hemodialysis treatment
Keywords
Hemodialysis treatment frequency, Elderly, Quality of Life, mortality
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Twice weekly hemodialysisOther

    Also called Twice weekly hemodialysis treatment

    Twice weekly hemodialysis

  • Thrice weekly hemodialysis treatmentOther

    This arm will receive three hemodialysis treatments per week

Study groups in NCT07738731
Study groupRoleWhat they receive
Twice weekly hemodialysis treatmentExperimentalThis arm will receive two hemodialysis treatments per week
Receives: Other: Twice weekly hemodialysis
Thrice weekly hemodialysis treatmentActive comparatorThis arm will receive three dialysis treatments per week
Receives: Other: Thrice weekly hemodialysis treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Days Alive and Out of Hospital

    Days Alive and Out of Hospital is an important patient-centered goal and outcome that approximates time spent at home.

    Measured: 365 days

Secondary outcomes (15)

  1. Days Alive and Out of Hospital

    Days Alive and Out of Hospital is an important patient-centered goal and outcome that approximates time spent at home

    Measured: 2 years

  2. Quality-adjusted life years

    Impact of treatment frequency on Quality-adjusted life years

    Measured: 2 years

  3. Change in Edmonton Symptom Assessment Scale-revised Renal score from baseline to average of all follow-up assessments

    Impact of treatment frequency on Quality of Life measures as assessed by the Edmonton Symptom Assessment Scale-revised Renal instrument (range 0-120 with higher scores mean a worse quality of life)

    Measured: 2 years

  4. Change in Kidney Dialysis and Quality of Life-36 scores from baseline to average of all follow-up assessments

    Impact of treatment frequency on quality of life as assessed by the Kidney Dialysis and Quality of Life-36 instrument (Each subscale score ranges from 0-100 where higher scores mean a better quality of life)

    Measured: 2 years

  5. Clinical Frailty Scale score

    Average of all follow-up Clinical Frailty Scale score assessments controlling for baseline (range 1-9 with higher scores meaning higher frailty)

    Measured: 2 years

  6. Number of urgent unscheduled hemodialysis treatment for hyperkalemia

    Impact of intervention on potassium control

    Measured: 2 years

  7. Number of urgent unscheduled hemodialysis treatment for volume overload

    Impact of treatment frequency on volume overload

    Measured: 2 years

  8. Weekly pre-hemodialysis potassium levels > 5.9 mmol/L

    Impact of treatment frequency on potassium control

    Measured: 2 years

  9. Change in urine volume

    Impact of treatment frequency on volume of urine output

    Measured: 2 years

  10. Hospitalization

    Impact of treatment frequency on the number and days of hospitalization

    Measured: 2 years

  11. Kidney function recovery

    Impact of treatment frequency on the number of participants recovering kidney function

    Measured: 2 years

  12. Elective withdrawal from hemodialysis treatment

    Impact of treatment frequency on the number of participants who choose to withdraw electively from hemodialysis treatment

    Measured: 2 years

  13. Cost

    Impact of treatment frequency on health care cost attributed to hemodialysis treatment

    Measured: 2 years

  14. Environmental costs attributed to hemodialysis treatment

    Impact of treatment frequency on the environmental cost attributed to hemodialysis treatment

    Measured: 2 years

  15. mortality

    impact of treatment frequency on mortality

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2031 (estimated)
  4. Study completionOct 2031 (estimated)

Resources

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
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07738731
Sponsor's protocol ID
6046152
Acronym
DLITE
Status last verified
Jul 2026
First submitted
27 Jul 2026
Last updated
31 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication

Publications

  • Moorman D, Pilkey NG, Goss CJ, Holden RM, Welihinda H, Kennedy C, Halliday SM, White CA. Twice versus thrice weekly hemodialysis: A systematic review. Hemodial Int. 2022 Oct;26(4):461-479. doi: 10.1111/hdi.13045. Epub 2022 Sep 12.

    PubMed 36097718

  • White CA, Day AG, Holden RM. Response to the Letter to the Editor Entitled "Twice- Versus Thrice-Weekly Hemodialysis in the Elderly: Are we 'DLITE'd? Kidney Int Rep. 2026 Jan 19;11(4):103782. doi: 10.1016/j.ekir.2026.103782. eCollection 2026 Apr. No abstract available.

    PubMed 41717127

  • White CA, Welihinda H, Day AG, Heyland DK, Holden RM. Pilot Randomized Trial of Dialysis Less Frequently in the Elderly: The DLITE Study. Kidney Int Rep. 2025 Sep 3;10(11):3796-3809. doi: 10.1016/j.ekir.2025.08.043. eCollection 2025 Nov.

    PubMed 41278339

Questions about this trial

What is this clinical trial studying?

A study testing Twice weekly hemodialysis and Thrice weekly hemodialysis treatment in people with Hemodialysis and End Stage Kidney Disease (ESKD), run by Queen's University at 11 sites 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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?

Contact Christine A White, MD (613-533-3134, cw38@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days Alive and Out of Hospital (time frame: 365 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07738731, which also lists 3 linked publications.

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 31 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in