Acute Kidney InjuryACTNCT07670520
Acute Kidney Injury In Care Transitions (ACT): Pragmatic Clinical Trial
A study testing Acute Kidney Injury in Care Transitions (ACT) in people with Acute Kidney Injury, run by Mayo Clinic at 3 sites in United States.
Trial summary
The purpose of this study is to determine the effect of a multidisciplinary intervention at care transitions for acute kidney injury survivors on patient-centered outcomes. 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?
- Acute Kidney Injury in Care Transitions (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,260 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Apr 2026to 31 Dec 2030
- 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
- Clinician subjects
- Hospital clinicians including physicians and advanced practice providers employed by Mayo Clinic and practicing at one of the four study sites
- Provide care for hospitalized patients with stage 2 or stage 3 acute kidney injury (AKI) who are expected to be discharged home and are not receiving dialysis
- Patient subjects:
- Adults ≥18 years old
- Meet KDIGO consensus criteria for stage 2 (moderate) or 3 (severe) AKI
- Residence within the study catchment area (southern Minnesota, northern Iowa, or western Wisconsin)
Who cannot join
- Clinician subjects: Physicians and advanced practice providers who:
- Care exclusively for pediatric patients (<18 years)
- Care exclusively for patients on palliative care
- Patient subjects
- Discharged to hospice care
- Require outpatient dialysis at discharge
Show all 10Show fewer
- Are admitted from or expected to be discharged to a skilled nursing facility
- Dementia Diagnosis
- Have undergone solid organ transplant within the past 100 days
- Decline authorization for use of their medical records for research
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54703
Mitchell C. Strand, 507-293-0952
Suhail B Shuja, M.D.
- Not yet recruiting
Mayo Clinic Health System-Mankato
Mankato, Minnesota, 56001
Mitchell C. Strand, 507-293-0952
Jing Miao, M.D., Ph.D.
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mitchell C. Strand, 507-293-0952
Erin F. Barreto, Pharm.D., Ph.D.
About this study
The purpose of this study is to determine the effect of a multidisciplinary intervention at care transitions for acute kidney injury survivors on patient-centered outcomes.
- Conditions
- Acute Kidney Injury
- Being tested
- Acute Kidney Injury in Care Transitions (ACT), Usual Care
- 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.
Acute Kidney Injury in Care Transitions (ACT)Behavioural
Clinicians will assign risk-individualized kidney health care prior to hospital discharge for acute kidney injury survivors. Low risk acute kidney injury survivors will receive education prior to hospital discharge, moderate risk acute kidney injury survivors will receive a referral to primary care for laboratory and clinical follow-up within approximately 14-days including a medication review by a pharmacist, and high risk acute kidney injury survivors will be referred to nephrologist-directed care including remote monitoring program (RPM) where available and aligned with the patients goals/values/preferences for up to 90 days after discharge for the highest risk patients.
Usual CareBehavioural
Physicians and nurse practitioners will provide standard of care education, labs, and clinical follow-up after discharge.
| Study group | Role | What they receive |
|---|---|---|
| Acute Kidney Injury in Care Transitions (ACT) Intervention | Experimental | Physicians and nurse practitioners randomized to the ACT intervention group will be provided access to augmented kidney care support for acute kidney injury patients prior to hospital discharge, individualized according to post-discharge risk. Receives: Behavioral: Acute Kidney Injury in Care Transitions (ACT) |
| Usual Care | Active comparator | Physicians and nurse practitioners randomized to the usual care group will provide standard of care education, labs, and clinical follow-up after discharge. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital-Free Days
Hospital-free days is defined as the total number of days a patient is alive and out of the hospital within the specified time frame.
Measured: 90 days, 180 days, 1 year
Secondary outcomes (17)
Unplanned hospital readmissions or acute care contact or death
Composite of unplanned hospital readmissions or care contact (emergency department visit or observation) or death
Measured: 90-days, 180-days, 1 year
Death
Death after discharge
Measured: 90-days, 180-days, 1-year
AKI recurrence
Total number of patients to experience a recurrence of acute kidney injury after discharge.
Measured: 90 days, 180 days, 1 year
Major Adverse Kidney Event
Composite of death, dialysis, or persistent kidney dysfunction described as a 30% decline in eGFR from baseline
Measured: 90-, 180- days
Change in Estimated Glomerular Filtration Rate (eGFR) from preadmission baseline
eGFRcreatinine will be estimated from available serum creatinines checked in routine clinical practice at the study time points, and absolute and relative change in eGFR in milliliters per minute per 1.73m2 will be determined.
Measured: 90 days, 180 days, 1 year
Chronic kidney disease (CKD)
Total number of patients with new or worsening chronic kidney disease (CKD) post discharge
Measured: 90 days, 180 days, 1 year
End-stage kidney disease (ESKD)
Total number of patients with end-stage kidney disease (ESKD) post discharge
Measured: 90 days, 180 days, 1 year
Kidney transplantation
Total number of patients that require kidney transplantation post discharge
Measured: 90 days, 180 days, 1 year
Major adverse cardiovascular event
Incidence of major adverse cardiovascular event
Measured: 90-days, 180-days, 1 year
Provider and laboratory follow-up
Cumulative incidence of provider (PCP or nephrologist) and laboratory (serum creatinine and urine protein analysis) follow-up
Measured: 30-days, 90-days, 180-days
Post-discharge serum creatinine evaluation
Assessment of serum creatinine in the post-discharge interval
Measured: time to first, 30-days, 90-days, 180-days
Post-discharge urine protein evaluation
Assessment of urine protein in the post-discharge interval
Measured: time to first, 30-days, 90-days, 180-days
Primary care follow-up
Occurrence of a completed primary care encounter after discharge
Measured: time to first, 30-days, 90-days, 180-days
Nephrology follow-up
Occurrence of completed nephrology follow-up during the post-discharge interval
Measured: time to first, 30-days, 90-days, 180-days
Pharmacist follow-up
Occurrence of a completed pharmacist encounter in the post-discharge interval
Measured: time to first, 30-days, 90-days, 180-days
Guideline concordant care
Occurrence of provider and laboratory and initiation of renin-angiotensin system inhibitors, sodium-glucose cotransporter-2 inhibitors, or glucagon-like peptide-1 agonists in CKD.
Measured: 90 days, 180 days, 1 year
Engaged in remote monitoring program (RPM) program
Total number of patients who submitted one or more sets of vitals/symptoms through the supplied technology or completed one of the scheduled laboratory assessments as part of the remote monitoring program (RPM)
Measured: 30 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start16 Apr 2026
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Barreto, Mayo Clinic
- Investigators
- Erin F. Barreto, Pharm.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670520
- Sponsor's protocol ID
- 25-009970
- Other IDs
- 1R01DK145433-01
- Acronym
- ACT
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study may be requested from other researchers five years after the completion of the primary endpoint by contacting the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury In Care Transitions (ACT): Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT07670520
- Acronym / sponsor ID
- ACT / 25-009970
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,260 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of a multidisciplinary intervention at care transitions for acute kidney injury survivors on patient-centered outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Kidney Injury in Care Transitions (ACT) Intervention | Experimental | Behavioral: Acute Kidney Injury in Care Transitions (ACT)Physicians and nurse practitioners randomized to the ACT intervention group will be provided access to augmented kidney care support for acute kidney injury patients prior to hospital discharge, individualized according to post-discharge risk. |
| Usual Care | Active comparator | Behavioral: Usual CarePhysicians and nurse practitioners randomized to the usual care group will provide standard of care education, labs, and clinical follow-up after discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinician subjects
- Patient subjects:
Key exclusion criteria (10 listed)
- Clinician subjects: Physicians and advanced practice providers who:
- Patient subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Kidney Injury in Care Transitions (ACT)Clinicians will assign risk-individualized kidney health care prior to hospital discharge for acute kidney injury survivors. Low risk acute kidney injury survivors will receive education prior to hospital discharge, moderate risk acute kidney injury survivors will receive a referral to primary care for laboratory and clinical follow-up within approximately 14-days including a medication review by a pharmacist, and high risk acute kidney injury survivors will be referred to nephrologist-directed care including remote monitoring program (RPM) where available and aligned with the patients goals/values/preferences for up to 90 days after discharge for the highest risk patients. | Behavioural | Acute Kidney Injury in Care Transitions (ACT) Intervention |
| Usual CarePhysicians and nurse practitioners will provide standard of care education, labs, and clinical follow-up after discharge. | Behavioural | Usual Care |
Primary outcome
Hospital-Free Days
Time frame: 90 days, 180 days, 1 year
Hospital-free days is defined as the total number of days a patient is alive and out of the hospital within the specified time frame.
17 secondary outcomes
Unplanned hospital readmissions or acute care contact or death
Time frame: 90-days, 180-days, 1 year
Death
Time frame: 90-days, 180-days, 1-year
AKI recurrence
Time frame: 90 days, 180 days, 1 year
Major Adverse Kidney Event
Time frame: 90-, 180- days
Change in Estimated Glomerular Filtration Rate (eGFR) from preadmission baseline
Time frame: 90 days, 180 days, 1 year
Chronic kidney disease (CKD)
Time frame: 90 days, 180 days, 1 year
End-stage kidney disease (ESKD)
Time frame: 90 days, 180 days, 1 year
Kidney transplantation
Time frame: 90 days, 180 days, 1 year
Major adverse cardiovascular event
Time frame: 90-days, 180-days, 1 year
Provider and laboratory follow-up
Time frame: 30-days, 90-days, 180-days
Post-discharge serum creatinine evaluation
Time frame: time to first, 30-days, 90-days, 180-days
Post-discharge urine protein evaluation
Time frame: time to first, 30-days, 90-days, 180-days
Primary care follow-up
Time frame: time to first, 30-days, 90-days, 180-days
Nephrology follow-up
Time frame: time to first, 30-days, 90-days, 180-days
Pharmacist follow-up
Time frame: time to first, 30-days, 90-days, 180-days
Guideline concordant care
Time frame: 90 days, 180 days, 1 year
Engaged in remote monitoring program (RPM) program
Time frame: 30 days, 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data from this study may be requested from other researchers five years after the completion of the primary endpoint by contacting the principal investigator.
Related trials for Acute Kidney Injury
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
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Acute Kidney Injury and Ultra-endurance Running
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
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Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin F. Barreto, Pharm.D., Ph.D. principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Kidney Injury in Care Transitions (ACT) in people with Acute Kidney Injury, run by Mayo Clinic at 3 sites in United States.
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 7 inclusion and 10 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 26 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 3 sites in United States. 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 Mitchell C. Strand (507-293-0952, strand.mitchell@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital-Free Days (time frame: 90 days, 180 days, 1 year). 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 26 Jun 2026.