An interventional study of Twice weekly hemodialysis and Thrice weekly hemodialysis treatment in Hemodialysis and End Stage Kidney Disease (ESKD), sponsored by Queen's University. Not yet recruiting at 11 sites in Canada. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Queen's University · Not applicable, Interventional, and Treatment
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 210 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Queen's University is the lead sponsor of 207 studies on the registry; 16 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This arm will receive two hemodialysis treatments per week
Other: Twice weekly hemodialysis
This arm will receive three dialysis treatments per week
Other: Thrice weekly hemodialysis treatment
Twice weekly hemodialysis
Also known as: Twice weekly hemodialysis treatment
This arm will receive three hemodialysis treatments per week
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.
Time frame: 365 days
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
Time frame: 2 years
Quality-adjusted life years
Impact of treatment frequency on Quality-adjusted life years
Time frame: 2 years
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)
Time frame: 2 years
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)
Time frame: 2 years
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)
Time frame: 2 years
Number of urgent unscheduled hemodialysis treatment for hyperkalemia
Impact of intervention on potassium control
Time frame: 2 years
Number of urgent unscheduled hemodialysis treatment for volume overload
Impact of treatment frequency on volume overload
Time frame: 2 years
Weekly pre-hemodialysis potassium levels > 5.9 mmol/L
Impact of treatment frequency on potassium control
Time frame: 2 years
Change in urine volume
Impact of treatment frequency on volume of urine output
Time frame: 2 years
Hospitalization
Impact of treatment frequency on the number and days of hospitalization
Time frame: 2 years
Kidney function recovery
Impact of treatment frequency on the number of participants recovering kidney function
Time frame: 2 years
Elective withdrawal from hemodialysis treatment
Impact of treatment frequency on the number of participants who choose to withdraw electively from hemodialysis treatment
Time frame: 2 years
Cost
Impact of treatment frequency on health care cost attributed to hemodialysis treatment
Time frame: 2 years
Environmental costs attributed to hemodialysis treatment
Impact of treatment frequency on the environmental cost attributed to hemodialysis treatment
Time frame: 2 years
mortality
impact of treatment frequency on mortality
Time frame: 2 years
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Study Protocol, ICF and CSR will be available as soon as they are finalized (anticipate 2026). The SAP will be made available prior to unlocking the data and conducting the analysis of the primary outcome (anticipated: 2031) The analytic code will be made available 6 months after publication (anticipated 2031)
Access criteria: The Principal Investigators will review requests for IPD sharing. Statistical methods for proposed analyses will be approved by independent review.
Start is estimated for Oct 2026; primary completion for Oct 2031, 60 months later.
Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 60 months is above that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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