Less Frequent Hemodialysis for Kidney Failure

(DLITE Trial)

Not yet recruiting at 9 trial locations
CA
Overseen ByChristine A White, MD
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Queen's University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for people aged 70 or older who have kidney failure and are just starting hemodialysis. Participants should be able to safely receive either two or three dialysis sessions per week, as determined by their medical team.

Inclusion Criteria

I have end stage kidney disease and need regular hemodialysis.
I am 70 years old or older.

Exclusion Criteria

Patients who are medically unsuitable as per primary care team and site investigator
Anticipated significant barriers to ascertainment of patient-reported experience measures
Hospitalized patients without an alternate level of care designation
See 2 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares getting hemodialysis twice a week versus the usual three times a week in elderly patients with kidney failure. Patients are randomly assigned to one of these groups to see if less frequent treatment is safe and improves quality of life.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Twice weekly hemodialysis treatmentExperimental Treatment1 Intervention
Group II: Thrice weekly hemodialysis treatmentActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Queen's University

Lead Sponsor

Trials
382
Recruited
122,000+