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Acute Kidney InjuryUPTAKE-1NCT05806645

UPTAKE: Using Personalized Risk and Digital Tools to Guide Transitions Following Acute Kidney Events

A study testing Risk-guided transition of care intervention delivered through an integrated digital health strategy in people with Acute Kidney Injury, run by University of Alberta at 2 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Nearly one in ten people who are hospitalized in Canada develop a complication with sudden loss of kidney function, called acute kidney injury (AKI). AKI may lead to other severe health problems after discharge home, such as kidney failure requiring dialysis treatment, heart failure, heart attacks, stroke, and even… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Kidney Injury
What is being tested?
Risk-guided transition of care intervention delivered through an integrated digital health strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,046 participants
Where
2 sitesCanada
Study dates
12 Feb 2025to Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (all of)
  • Age ≥ 18 years old
  • Hospitalized at site using AHS EHR
  • Acute Kidney Injury (Stage 1-3) identified in hospital per KDIGO guideline criteria

Who cannot join

  • (any of)
  • Pre-hospitalization advanced CKD: eGFR<30 mL/min/1.73m2
  • Pre-hospitalization dialysis
  • Very low risk (<1% risk) of advanced CKD
  • Non-Alberta resident
  • Palliative goals of care
Show all 14Show fewer
  • Enrolled in the UPTAKE VC Trial
  • Admitted under a nephrologist at time of discharge
  • Dialysis on at least 2 days in the last week prior to discharge
  • Receiving apheresis
  • Kidney transplant recipient
  • Kidney transplant donor
  • Diagnosis of Glomerulonephritis
  • Cirrhosis AND complication of cirrhosis in medical history or active problem list (ascites, varices, hepatic encephalopathy, hepatorenal syndrome)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Canada2 sites, 2 recruiting
  • Foothills Medical Centre

    Calgary, Alberta

    Matt James, mjames@ucalgary.ca

    Recruiting
  • University of Alberta Hospital

    Edmonton, Alberta

    Neesh Pannu, npannu@ualberta.ca

    Recruiting

Other trials in Canada

About this study

Official title: UPTAKE: Using Personalized Risk and Digital Tools to Guide Transitions Following Acute Kidney Events- A Pragmatic Randomized Controlled Trial in Connect Care

Nearly one in ten people who are hospitalized in Canada develop a complication with sudden loss of kidney function, called acute kidney injury (AKI). AKI may lead to other severe health problems after discharge home, such as kidney failure requiring dialysis treatment, heart failure, heart attacks, stroke, and even premature death. Discharge from hospital to home can be a difficult transition where there are often gaps in identification, communication, care coordination, education, and planning of care for AKI. The study team will co-design and evaluate a tailored post-discharge care plan that is based on the risk of later kidney problems and uses currently available, yet untapped digital innovation to improve the health and experience of people with AKI.

This study will be built into Alberta's new Epic Systems based provincial electronic health record (EHR). The plan is to use digital tools in the EHR to identify all people in Alberta hospitals that have had an AKI event and are at increased risk of long-term complications. Half will randomly be assigned to receive a tailored care plan based on their risk at hospital discharge while the other half will receive care as it is currently provided by their healthcare team. The electronic health system will automatically calculate a patient's risk and report this risk in their chart along with recommendations for care. The study team includes patients, healthcare providers, and health system decision makers needed to co-develop the proposed strategy and introduce the changes needed to deliver this intervention. The investigators will study whether this strategy can reduce health problems that may happen after AKI including death, chronic kidney disease (CKD), kidney failure, heart attacks, and stroke. The investigators will also determine if the approach improves patient experience during the transition from hospital to home. This study has the potential to revolutionize how we care for people that leave hospital after having AKI.

Read the detailed description

Acute kidney injury (AKI) is common in hospitalized patients and associated with poor long-term outcomes including kidney failure, cardiovascular (CV) events, and death, with highest risk in older adults. The transition of hospitalized patients with AKI to home is challenging, with many care gaps. Identifying those at highest risk of adverse post-discharge outcomes and delivering interventions to reduce the risk of progressive kidney and CV disease via appropriate, acceptable, and efficient intervention strategies are needed. Our team has developed and externally validated a risk prediction model for hospitalized adults with AKI, which can estimate the risk of advanced chronic kidney disease (eGFR<30mL/min/1.73m2 or kidney failure). The investigators used this risk model to guide follow-up in a pilot trial for AKI survivors within Alberta (ClinicalTrials.gov: NCT02915575). The investigators have found that a risk-guided strategy to follow-up is a feasible approach to close gaps in care; however, larger studies are required to evaluate broader implementation, and impact on patient-centered outcomes, costs, and sustainability in a real-world setting. Alberta Health Services (AHS) has implemented a new province-wide clinical information system which provides a unique opportunity to use digital health technology to design and evaluate a risk-guided hospital-to-home transition of care intervention that builds upon previous work.

OBJECTIVES AND METHODS:

  1. To co-develop a risk-guided intervention with patients, clinicians, and health system decision-makers to improve personalized transitions of care between hospital and home for survivors of AKI. The investigators will use a participatory research approach that engages patients and care providers to co-design an evidence-guided, experience-based intervention for AKI transitions in care. Qualitative methods will be used to identify and prioritize transition interventions aligned with patient risk of adverse post-discharge outcomes.
  2. To a) identify key service delivery supports required to integrate the AKI hospital to home transition of care intervention and b) establish usability and acceptability of the intervention within the electronic health record. With the support of the AHS and existing hospital to home transition initiatives, the investigators will work with key health system partners to integrate developed AKI transition of care intervention within the EHR. The investigators will use a mixed methods approach to identify barriers and enablers to implementation and establish usability and acceptability of the intervention.
  3. To evaluate the effectiveness of this intervention in a pragmatic clinical trial that will measure implementation success and impact on patient experience, outcomes, and costs. Using the EHR, hospitalized adults with AKI at increased risk of adverse long-term outcomes will be randomized to the risk-guided transition intervention or usual care. The risk-guided arm will receive the interventions identified in Objective 1 tailored based on their clinical profile and risk of CKD from the prediction model. The primary outcome of the trial is the two-year risk of a composite of death, kidney failure, or major CV event. 6,046 patients are required to detect a 15% relative risk reduction of the primary outcome, with 90% power. Effects on patient experience, processes of care, implementation, and costs will also be evaluated.
Being tested
Risk-guided transition of care intervention delivered through an integrated digital health strategy
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risk-guided transition of care intervention delivered through an integrated digital health strategyOther

    Patients will receive transition of care plans that are tailored to their medical profile and risk and embedded within standardized discharge pathways within the EHR- Education and self-management guidance about AKI for patients, Medication guidance based on evidence-based indications for reducing risk of cardiac and kidney outcomes, Recommendations for subsequent laboratory testing of kidney function, proteinuria and electrolytes according to clinical characteristics and risks, Recommendations for timing and nature of PCP follow-up, Information about the patient's AKI and subsequent management provided to PCPs through discharge summary, Recommendations for outpatient Pharmacy follow-up for medication reconciliation and review according to patient risk and medication management gaps, Recommendations for Nephrology referral for high risk patients

Study groups in NCT05806645
Study groupRoleWhat they receive
InterventionExperimentalThe proposed experimental intervention will incorporate our risk prediction model which will be used in combination with a patients medical profile to guide the hospital to home transition of care for low, medium and high-risk groups of patients. Patients will receive transition of care plans that are tailored to their medical profile and embedded within standardized discharge pathways within the electronic health record
Receives: Other: Risk-guided transition of care intervention delivered through an integrated digital health strategy
Usual CareNo interventionThe usual care group will not receive the risk-guided transition of intervention and will receive standard hospital discharge care in accordance with local health system standards (Alberta Health Services), with recommendations for kidney function, proteinuria and laboratory testing at 90 days after discharge.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary effectiveness outcome

    The primary outcome of the study is major adverse kidney or CV events within 2 years after discharge, defined as the composite of death, kidney failure (receipt of maintenance dialysis, kidney transplant or eGFR < 15 mL/min/1.73m2 for 4 weeks or more), or hospitalization with a most responsible diagnosis for heart failure, myocardial infarction, or stroke (based on validated ICD-10 coding algorithms)

    Measured: 2 years after discharge

Secondary outcomes (9)
  1. Secondary Clinical Outcomes-Death

    Death from any cause within 2 years of discharge

    Measured: 2 years of discharge

  2. Safety Outcomes- Hyperkalemia

    Serum potassium ≥ 6.0 mEq/L on outpatient lab testing within one year of discharge

    Measured: within 1 year of discharge

  3. Safety Outcomes-Hospitalization for Kidney Disease Ambulatory Care Specific Condition

    Hospitalization for a Kidney Disease Ambulatory Care Specific Condition (Congestive Heart Failure, Volume Overload, Hyperkalemia, or Hypertensive Emergency) within one year after discharge (based on ICD-10 coding algorithms)

    Measured: within 1 year of discharge

  4. Safety Outcomes-All Cause Hospitalization or ED Visit

    All-cause hospitalization or ED visits within 30 and 90 days of discharge

    Measured: 30 and 90 days of discharge

  5. Secondary Clinical Outcomes-Kidney Failure

    Receipt of maintenance dialysis, kidney transplant, or eGFR < 15 mL/min/1.73m2 for 4 weeks or more) within 2 year of discharge

    Measured: within 2 years of discharge

  6. Secondary Clinical Outcomes-Hospitalization for CV Events

    Hospitalization with a most responsible diagnosis for heart failure, myocardial infarction, or stroke (based on validated ICD-10 coding algorithms) within 2 years of hospital discharge

    Measured: Within 2 years of hospital discharge

  7. Patient Experience

    Patient experience will be assessed using a survey with eight questions related to AKI transition in care administered by AHS via phone at 6 ± 2 weeks post discharge to a random estimated 10% of patients in both control and intervention arms of the study. The sampling frame will be designed to recruit an equal number of patients from each CKD risk strata.

    Measured: 6 ± 2 weeks post discharge

  8. Implementation Outcomes

    Implementation outcomes will include the proportion of eligible patients included in the study who receive each element of the enhanced care intervention that is recommended by the practice advisory, according to their risk strata. These will include documentation of AKI in the problem list, AKI discharge communication sent to the patient's primary care provider at discharge, after visit summary printed for the patient prior to discharge, referral to community pharmacist when recommended, referral to nephrologist when recommended, and laboratory test (eGFR, urine ACR, electrolytes) ordered for within 2 or 4 weeks of discharge according to recommendations.

    Measured: 2 or 4 weeks of discharge

  9. Process of Care Outcomes

    Process of care outcomes will include the proportion of patients who receive the recommended kidney function monitoring (eGFR, urine ACR, electrolytes) within 2 or 4 weeks after discharge, the proportion of patients with a recommendation for and who receive a guideline-indicated medication for kidney and cardiovascular risk reduction (RAAS blockers, SGLT-2 inhibitors, finerenone, and statin prescription) within 90 days of discharge, the proportion of patients reviewed by a community pharmacist within 4 weeks when recommended, and the proportion of patients seen by a nephrologist within 4 weeks when recommended.

    Measured: within 2 or 4 weeks or 90 days of discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2023
  2. Study start12 Feb 2025
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
6,046 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05806645
Sponsor's protocol ID
UPTAKE Pro00128939
Acronym
UPTAKE-1
Status last verified
Jun 2026
First submitted
22 Mar 2023
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Risk-guided transition of care intervention delivered through an integrated digital health strategy in people with Acute Kidney Injury, run by University of Alberta at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Neesh Pannu (780 492 8519, npannu@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary effectiveness outcome (time frame: 2 years after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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UPTAKE-1 Clinical Trial NCT05806645 | AzTrials