An interventional study of VIEWER virtual care platform in Chronic Kidney Disease Stage 5 and End Stage Renal Disease, sponsored by University of Manitoba. Recruiting at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by University of Manitoba · Not applicable, Interventional, and Supportive care
Among 134 studies in Kidney Failure, Chronic with a site in Canada — 20 open to participants now, 28 under way, 4 of them phase 3. Kidney Failure, Chronic · Canada.
Among the 134 studies in Kidney Failure, Chronic with a site in Canada, this one is the 19th largest by planned enrollment of the 110 interventional ones, is one of 11 that started in 2022, is one of 50 with no phase, reaches primary completion later than 13 of the 27 other live ones, and was the 104th registered.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 340 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →20 of the 134 studies in Kidney Failure, Chronic with a site in Canada are open now, in 12 countries. Each count lists the studies.
Of the 170 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →134 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 11 started in 2022.
Median enrollment 79 across the 110 interventional studies, 109 across the 24 observational. Of the 91 that completed or were terminated, 17 (19%) have results posted.
26 of 134 have an industry lead sponsor. The 10 most frequent:
University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
University of Manitoba has 7 studies filed under Kidney Failure, Chronic — fewer than ten, so there is no comparison to draw.
9 of the studies in Kidney Failure, Chronic with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05715814Phase 3University Health Network, TorontomeChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis | 2027-05-01 |
| NCT02823821University of SydneyRandomised Evaluation of Sodium Dialysate Levels on Vascular Events | 2026-12 |
| NCT05968391Université de SherbrookeAcetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP) | 2026-12-15 |
| NCT04603014London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sInterdialytic Peritoneal UltraFiltration in HemoDialysis Patients | 2026-12-30 |
| NCT06032208London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sAn Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL | 2026-12-31 |
Among the 134 studies in Kidney Failure, Chronic with a site in Canada, from their registry updates:
The main purpose of this trial is to determine whether the addition of the VIEWER virtual care platform to usual care will lead to a reduction in composite emergency department (ED) visits and/or hospitalizations/or increase the perceived safety of virtual care among patients and providers.
Background: Chronic Kidney Disease (CKD) is an increasingly prevalent condition that represents a major national public health burden. The health transition from advanced CKD to the start of dialysis is a period of heightened vulnerability for many patients. Our data has demonstrated that during the 30-day period before the start of dialysis, there is a 10-fold increase in Emergency Department (ED) visits and hospitalizations related to kidney failure and its complications. Importantly, this spike occurs despite patients having frequent contact with their nephrology healthcare teams. For stable CKD patients, virtual monitoring could facilitate the communication of accurate and reliable data between patients and providers helping to avoid unnecessary ED visits and facilitate more optimal dialysis starts.
Design\& Method: The VIEWER study is a national, pragmatic, multicenter randomized controlled trial across 5 Canadian sites from two provinces including:
VIEWER is a CKD-specific virtual care platform that integrates data from a wireless Blood Pressure (BP) cuff, weight scale, transcutaneous O2 sat monitor, and wearable motion tracker. The patient-facing component of VIEWER (patient portal), is a custom application based on a mobile tablet that guides patients through a daily self-assessment routine using the connected devices. BP measurements, weight and oxygenation (as surrogates of volume status), and step counts (as a surrogate of functional status), provide semi-continuous longitudinal data on patient physical status. Additionally, patients are prompted to fill out a weekly symptom survey (Edmonton Symptom Assessment Score- revised; ESAS-r), a validated instrument of kidney failure symptoms. Patient data and ESAS scores are automatically uploaded to fully PHIA/HIPPA compliant servers where they are made available to the patients' care team through a secure, web-based provider portal. Provider notifications (flags) are generated for out-of-range values (i.e. BP, weights for volume management) and a secure messaging component allows for direct patient-provider communication. Participants will be trained to use the VIEWER platform by a member of the research team. On the provider side, two members of the care team at each site will be trained as "superusers" of the provider portal. These users will check and respond as needed daily (Monday to Friday) for flags and patient messages, and will respond or communicate as needed to the health care team as per local clinic standard operating procedures. Trends in measurements will be reviewed at multidisciplinary team rounds, which typically occur weekly. During routine clinic visits, trends in all objective and subjective measures will be available to review to inform clinical decision making. Consistent with our pragmatic design, we will not be proscriptive in how monitoring data are interpreted; rather, we ask that care teams consider this enriched data stream and incorporate that information according to their own protocols and clinical judgement.
Patients randomized to the control group will see their multidisciplinary CKD care teams as per usual care.
Follow-up visits and Focus Groups (or individual interview): Patient Reported Experience Measures (PREM) and Kidney Disease Quality of Life-Short Form (KDQOL-SF) will be measured at baseline, 3, 6, 9 and 12 months in all paticipanats. Usability, acceptability, and patient and provider perspective on the intervention will be assessed at the end of the trial using the System Usability Scale (SUS). In addition, two virtual focus groups will be conducted at the end of the study with a subset of participants and healthcare providers who used the VIEWER platform.
Statistical Methods:The primary outcome (time to first hospitalization or ED visit, censoring at dialysis or death) will be assessed using univariate Cox proportional hazards models and a Kaplan-Meier analysis with a log-rank test, as will the secondary outcomes of all-cause mortality, ED visits, hospitalization, and acute inpatient dialysis initiation. Change in overall PREM, KDQOL-SF and SUS scores will be assessed with two-sided t-test or Wilcoxon Rank Sum test as distributionally appropriate, and interpreted relative to their minimal important differences. All outcomes will be assessed at a two-sided alpha= 0.05. Subgroup analyses will be prespecified and limited to 1) eGFR greater or less than 10ml/min, 2) sex and gender (described below) 3) diabetes.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 340 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Compared within Kidney Failure, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Renal Insufficiency, Chronic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the intervention group will be provided with a wireless BP cuff, weight scale, transcutaneous O2 sat monitor, wearable motion tracker and mobile tablet with the VIEWER application. Patients will be trained to use the VIEWER platform either virtually or in person. Patients will be guided through a daily self-assessment routine via the app (BP, weight, O2 saturation, step count upload) and weekly ESAS-r survey. Participants will use the VIEWER platform for 12 months ( or until dialysis initiation) in addition to receiving usual care. Additionally, participants will complete the UK Kidney PREM score (adapted to CKD) and the Health related QOL using KDQOL-SF via REDCap or paper form at baseline, 3, 6, 9 and 12 months (or every 3 months until dialysis initiation), and the System Usability Scale (SUS) at 12 months.
Device: VIEWER virtual care platform
Participants randomized to the control group will continue to receive usual care either virtually via telephone or video call or in person depending on COVID-19 restrictions in place. Participants will complete the UK Kidney PREM score (adapted to CKD) and the Health related QOL using KDQOL-SF via REDCap or paper form at baseline, 3, 6, 9 and 12 months (or every 3 months until dialysis initiation).
VIEWER is a tablet based, CKD specific home telemonitoring platform developed by our team of patients and researchers that integrates data from a wireless blood pressure cuff, weigh scale, transcutaneous O2 sat monitor and wearable motion tracker via a tablet and custom app.
Composite of first hospitalization or emergency department (ED) visit
It's defined as an inpatient admission to hospital or a visit to the emergency department, whatever is first". So, we will compare the time of the first hospital admission /and or ED visit between two groups.
Time frame: 12 months or until dialysis initiation
All-cause mortality
The mortality rate will be compared between the intervention and control group.
Time frame: 12 months or until dialysis initiation
Proportion of patients who have an acute inpatient initiation of dialysis.
the rate of patients who started dialysis in the intervention and control groups during 1 year of follow-up.
Time frame: 12 months or until dialysis initiation
Frequency of Emergency Department Visit
The average frequency of ED visit will be compared in two study groups.
Time frame: 12 months or until dialysis initiation
Frequency of formal clinic visits
The average frequency of formal clinic visits will be compared between two study groups
Time frame: 12 months or until dialysis initiation
UK Kidney PREM score (adapted to CKD)
The UK Kidney Patient Reported Experience Measure is a validated, self-reported scale that focuses on how kidney patients experience care. The UK Kidney PREM used for this trial consists of questions abstracted from the 2019 Kidney PREM. Possible scores range from 1 (strongly disagree) to 10 (strongly agree). The average total scores will be compared between intervention and control group.
Time frame: baseline, 3, 6, 9 and 12 months (or every 3 months until dialysis initiation)
Health related QOL using KQOL-SF
Kidney Disease Quality of Life- Short Form is a self-reported measure developed for individuals with kidney disease and those on dialysis. It includes 43 kidney disease targeted items, and 36 items that provide a measure of physical and mental health and 1 overall health rating item ranging from 0 (worst possible health) to 10 (best possible health).The average total scores will be compared between intervention and control groups.
Time frame: baseline, 3,6,9 and 12 months (or every 3 months until dialysis initiation)
System Usability Scale (SUS)
The System Usability Scale measures the usability of a wide range of products and services including hardware and software. It consists of a 10 item questionnaire with 5 response options ranging from 1 (strongly disagree) to 5 (strongly agree). This will be assessed via focus groups held with a subset of patients.
Time frame: 12 months ( or at the time of dialysis initiation)
Provider Perspectives towards intervention (qualitative) focus groups
Assessed via focus groups held with a subset of providers
Time frame: 12 months (or end of study)
Patient Perspectives towards intervention (qualitative) focus groups (or individual interview)
Assessed via focus groups held with a subset of patients
Time frame: 12 months (or end of study)
Proportion of patients greater than 80% adherence
tracked via VIEWER app
Time frame: 12 months (or end of study)
Plan to share: No
Started Jun 2022 (actual). Primary completion is estimated for Mar 2027, 57 months after the start.
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 57 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.
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