Dialysis Less Frequently in the Elderly

NCT07738731 | Not Yet Recruiting

• 1 other identifier: 6046152
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 11

Brief 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. 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.

Conditions

Hemodialysis; End Stage Kidney Disease (ESKD)

Keywords

Hemodialysis treatment frequency; Elderly; Quality of Life; mortality

Outcome Measures

Primary Outcomes (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.

  365 days

Secondary Outcomes (15)

• Days Alive and Out of Hospital

  2 years

• Quality-adjusted life years

  2 years

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

  2 years

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

  2 years

• Clinical Frailty Scale score

  2 years

Study Arms (2)

Twice weekly hemodialysis treatment

EXPERIMENTAL

This arm will receive two hemodialysis treatments per week

Other: Twice weekly hemodialysis

Thrice weekly hemodialysis treatment

ACTIVE COMPARATOR

This arm will receive three dialysis treatments per week

Other: Thrice weekly hemodialysis treatment

Interventions

Twice weekly hemodialysis OTHER

Twice weekly hemodialysis

Also known as: Twice weekly hemodialysis treatment

Twice weekly hemodialysis treatment

Thrice weekly hemodialysis treatment OTHER

This arm will receive three hemodialysis treatments per week

Thrice weekly hemodialysis treatment

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (11)

Multiple Sites

Vancouver, British Columbia, Canada

Location

Memorial University

St. John's, Newfoundland and Labrador, Canada

Location

Dalhousie University

Halifax, Nova Scotia, Canada

Location

Queen's University

Kingston, Ontario, K7L 4B7, Canada

Location

CHUM

Montreal, Quebec, Canada

Location

Hopital du Sacre-Coeur-de-Montreal

Montreal, Quebec, Canada

Location

Hopital du Sacre-Coeur-de-Montreal

Montreal, Quebec, Canada

Location

Hopital Maisoneuve-Rosemont

Montreal, Quebec, Canada

Location

Hôpital du Haut-Richelieu

Montreal, Quebec, Canada

Location

McGill University

Montreal, Quebec, Canada

Location

Centre de Recherche du CHU de Quebec: Laval University

Québec, Quebec, Canada

Location

Related Publications (3)

• 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.

  PMID: 36097718 BACKGROUND

• 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.

  PMID: 41717127 BACKGROUND

• 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.

  PMID: 41278339 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christine A White, MD

CONTACT

613-533-3134; cw38@queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1. Study Protocol, ICF and CSR will be available as soon as they are finalized (anticipate 2026). 2. The SAP will be made available prior to unlocking the data and conducting the analysis of the primary outcome (anticipated: 2031) 3. 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.

Locations

CA (11)