Recruiting

Expanded Dialysis

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT06032208

Conditions

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Theranova Dialyzer

Study Details

Brief summary:

Investigators know that many patients who are on dialysis suffer from burden of unwanted symptoms, which can affect quality of life. The understanding and treatment of symptom burden by healthcare providers is limited and should be recognized as a high priority in the care of the dialysis population. In this study, the investigators will be assessing symptom burden using the London Evaluation of Illness "LEVIL," an application based platform where patients self-report their symptoms with one to three hemodialysis treatments per week for 28 weeks. The investigators would like to compare the currently available dialyzer with a new dialyzer that is capable of removing solutes of higher molecular weight that may or may not cause patients to experience symptoms related to increased amounts of toxins in their blood.

Conditions

End Stage Renal Disease

Study ID

NCT06032208

Start date

Mar 1, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Conventional thrice weekly HD schedule
  • Must be on chronic hemodialysis for at least 3 months
  • Age ≥18 years
  • Willing and able to give informed consent

Exclusion Criteria:

  • Active infection (may enroll once infection is cleared)
  • Patients receiving daily hemodialysis treatment
  • Patients currently receiving Hemodiafiltration (HDF), Hemofiltration (HF) or Isolated ultrafiltration (ISO UF) more than once in three months
  • Visual impairment
  • History of neurocognitive impairment
  • History of stroke (CVA)

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients receiving Hemodialysis

A group of hemodialysis patients will be receiving the Theranova dialyzer during their regular scheduled dialysis sessions to remove larger middle molecules.

Interventions

Theranova Dialyzer

The Theranova dialyzer will be used for each of the hemodialysis treatments beginning week 5 and ending at the end of dialysis week 28. This will allow us to compare patient reported symptoms in weeks 1-4 on their usual dialyzer with with their symptoms on the Theranova dialyzer.

Primary outcome measure

  • Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx -Theranova) effects patient reported symptoms as determined by LEVIL. [ Time Frame: Beginning week 1 and ending at the end of dialysis on week 28. ]

Central Contacts and Locations

Central contacts

Christopher McIntyre, MBBS DM

5196858500Christopher.McIntyre@lhsc.on.ca

Jarrin Penny, PHD RN CNeph

519-685-8500jarrin.penny@lhsc.on.ca

Locations

Seven Oaks Hospital Chronic Disease Innovation Centre Inc. (CDIC)

Recruiting

Winnipeg, Manitoba, Canada, R2V 3M3

Contacts

Jordan Bankowski, BSc

(204) 631-3834jbankowski@sogh.mb.ca

Oksana Harasemiw Harasemiw

(204) 632-3541oharasemiw@sogh.mb.ca

Principal Investigator:

Clara Bohm, MD, MPH, FRCPC

QEII Health Sciences Centre, Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada, B3H 1V7

Contacts

Laura Sills, RN, BSN

(902) 473-7625laura.sills@nshealth.ca

Principal Investigator:

David Clark, MD, MSc, FRCPC

Victoria Hospital, London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Jarrin D Penny, RN

519-685-8500jarrin.penny@lhsc.on.ca

Westmount Kidney Care Centre

Recruiting

London, Ontario, Canada, N6K 1M6

Contacts

Jarrin D Penny, RN

519-685-8500jarrin.penny@lhsc.on.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Hemodialysis
  • Large middle molecules
  • Theranova

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2026-05-04.