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Effect of Extended Dialysis on Patient Reported Symptoms Using LEVIL

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ClinicalTrials.gov Identifier: NCT03640858
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : September 18, 2020
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Chris McIntyre, Lawson Health Research Institute

Brief Summary:
Investigators know that many patients who are on dialysis suffer from the burden of unwanted symptoms, which can affect quality of life. 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 at least one hemodialysis treatment. 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 these toxins in their blood.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Device: Theranova Dialyzer Not Applicable

Detailed Description:

Baxter Canada has an expanded hemodialysis (HDx) membrane called the "Theranova", which is capable of removing solutes of higher molecular weight. Although this clearly has biochemical advantages it is not known at this time if the removal of larger middle molecules can have a direct and immediate effect on patients reported symptoms and quality of life. In short, do be people actually feel better?

Given the way many QoL measurements fluctuate around the dialysis week, the investigators propose to utilize a dynamic tool. 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 at least one hemodialysis treatment. Reports are generated immediately and in real-time, which cannot be accomplished with other symptom management tools. This allows the investigators to track study changes and benchmark observations to previously established baseline values. The investigators are excited to see if there is an imminent effect on how patients feel using the Theranova dialyzer.

The study is investigator initiated and the principal investigator has secured modest funding from Baxter to allow support for the core study team and the introduction and maintenance of the LEVIL evaluation platform at other centers. Baxter have also provided some dialyzer support, and will work with individual centers to ensure that there is no consumable increment of cost associated with participation.

The study is 54 weeks in length:

  • LEVIL entries with at least one hemodialysis treatment each week for 54 weeks
  • Blood sampling at 2 time points for all participants and at 3 time points for LHSC participants only
  • Implementation of Theranova dialyzer from weeks 3 through 14 and weeks 23 through 46
  • Wash out period from weeks 15 through 22 and weeks 47 through 54
  • Time to recovery question at the first treatment of weeks 1, 14, 22, and 46 for new participants
  • 5-D Pruritus scale and Restless Legs Syndrome rating scale at the first treatment of weeks 1, 14, 22, and 46
  • Echocardiogram prior to starting hemodialysis and at peak stress at baseline (within the first two weeks), with one treatment between weeks 10 to 14 which will occur mid-week, and with one treatment between weeks 42 to 46 which will occur mid-week (LHSC specific)
  • CVInsight monitoring at baseline (within the first two weeks), with one treatment between weeks 10 to 14, and with one treatment between weeks 42 to 46 (LHSC specific)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Study visits take place within the patients' usual hemodialysis unit consistent with their routinely scheduled dialysis sessions. Beginning week 3 and 23 participants use the Theranova dialyzer until the end of the dialysis week on week 14 and 46. Participants answer 9 questions with at least one session regarding symptoms experienced since their last session using the LEVIL application. Furthermore, participants answer a single time to recovery question at the first treatment of weeks 1, 14, 22, and 46 to get more detailed information on recovery time after dialysis in addition to completing the 5-D Pruritus and the Restless Legs Syndrome scales.

Bloodwork is drawn at 3intervals throughout the study for laboratory evaluation.

Participants have an echo at baseline and once between weeks 10 to 14 while on the Theranova dialyzer. In addition to this, participants will have non-invasive monitoring of circulatory stress using the CVInsight contact device at the same time intervals.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional Study to Assess the Effect of Extended Dialysis Using the Theranova Dialyzer on Patient Reported Symptoms Using the London Evaluation of Illness (LEVIL)
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Patients receiving hemodialysis
A group of hemodialysis patients will be receiving the Theranova dialyzer during their regularly scheduled sessions to remove larger middle molecules
Device: Theranova Dialyzer
The Theranova dialyzer will be used for each of the hemodialysis treatments beginning week 3 and ending at the end of the dialysis week on week 14 and again starting week 23 and ending at the end of the dialysis week on week 46 . This will allow us to compare patient reported symptoms in weeks 1 and 2 when patients are on their usual dialyzer with their symptoms using the Theranova dialyzer. This will also allow us to see if there is a carry-over effect.




Primary Outcome Measures :
  1. A change in larger middle molecule induced symptoms as assessed by the LEVIL application [ Time Frame: Beginning week 1 and ending at the end of the dialysis week on week 46 ]
    The primary outcome will be a change (from patient's own baseline) in general well-being, pain, sleep, breathing, energy, appetite, itch, restless legs, and recovery from hemodialysis when using the Theranova dialyzer. These parameters will be measured using the LEVIL an electronic application based visual analog scale.


Secondary Outcome Measures :
  1. A change in larger middle molecule clearance using the Theranova dialyzer [ Time Frame: First treatment of weeks 1, 14, and 46 ]
    The secondary outcome is a change in the clearance of large middle molecules which will be evaluated by measuring levels of beta-2 microglobulin, beta-12 binding globulin, free light chains (kappa, lambda), factor D, fibroblast growth factor 23, and interleukin 6.

  2. Correlation between large middle molecules and patient symptoms [ Time Frame: Beginning week 1 and ending at the end of the dialysis week on week 54 ]
    Another secondary outcome is the relationship between the clearance of large middle molecules and specific symptoms reported by the patients using the LEVIL application.

  3. A change in symptoms with a change in dialyzer (usual to Theranova and vice versa) [ Time Frame: Beginning week 1 and ending at the end of the dialysis week on week 54 ]
    Another secondary outcome is if the time point where symptoms change with a change in dialyzer

  4. Effect on microcirculation and/or hemodialysis induced circulatory stress with the Theranova dialyzer [ Time Frame: Beginning week 3 and ending at the end of the dialysis week on week 14 and again week 23 and ending week 46 ]
    Another secondary outcome is the Theranova dialyzer effect on microcirculation and/or hemodialysis induced circulatory stress



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic hemodialysis patient
  • Must be on hemodialysis for at least 3 months
  • Age ≥18 years
  • Willing and able to give informed consent

Exclusion Criteria:

• Not meeting inclusion criteria


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640858


Contacts
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Contact: Christopher McIntyre, MBBS DM 5196858500 ext 58502 Christopher.McIntyre@lhsc.on.ca
Contact: Jarrrin Penny, RN BSN 5196858500 ext 58765 Jarrin.Penny@lhsc.on.ca

Locations
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Canada, Ontario
Adam Linton Dialysis Unit Recruiting
London, Ontario, Canada, N6A 5W9
Kidney Care Centre Recruiting
London, Ontario, Canada, N6K 1M6
Contact: Jarrin Penny    5196858500 ext 58765      
Sponsors and Collaborators
Lawson Health Research Institute
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Christopher McIntyre, MBBS DM London Health Sciences Centre
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Responsible Party: Chris McIntyre, Professor of Medicine, Medical Biophysics and Paediatrics, Robert Lindsay Chair of Dialysis Research and Innovation, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03640858    
Other Study ID Numbers: 1589
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chris McIntyre, Lawson Health Research Institute:
Hemodialysis
Larger middle molecules
Theranova
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency