Acute Kidney InjuryEarly Phase 1NCT06124924
SGLT2 Inhibitors After Acute Kidney Injury With Indications Pilot
A Early Phase 1 study testing SGLT2 inhibitor in people with Acute Kidney Injury, run by University of Minnesota at 1 site in United States.
Trial summary
SGLT2i have been shown to reduce risk for mortality, progression of chronic kidney disease, and cardiovascular outcomes in these populations. Yet, because SGLT2i can have an acute hemodynamic effect on kidney function, in clinical practice providers are wary of providing these medications to patients who have… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- SGLT2 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 16 Aug 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus, as indicated by review of the candidate's chart, as confirmed by interviewing the participant prior to randomization as part of the consent process, and documentation of at least one non-insulin diabetes medication that are specific to type 2 diabetes mellitus (with concurrent insulin use allowed) based on outpatient medication reconciliation documented in the inpatient medical notes and medication tab of Epic. SGLT2i are considered first- line therapy for type 2 diabetes mellitus.
- Age 40 to 75 years at time of screening. This age range is chosen to decrease the likelihood of pregnancy while also increasing the likelihood of participants having adequate life expectancy to benefit from SGLT2i use.
- No positive pregnancy test results during the current hospitalization (or from a transferring hospital or transferring emergency room) or documentation in the electronic medical chart of an existing pregnancy. For candidates for the study who are female of childbearing age \<55 years (an approximate upper limit for menopause) with a urine sample in the UMMC laboratory available to add-on a urine pregnancy test, Dr. Murphy will ask the primary team or nephrology team to add-on that test if medical relevant (pregnancy is virtually always medically relevant). If they cannot (because no urine sample is available or they determine it is not medically relevant), that patient will no longer be considered a study- candidate.
- AKI occurring during the index hospitalization or present-on-admission, with a nephrology consult active after the onset of the AKI. The nephrology consult team need not be active at the time of study enrollment, though, if not medically needed any longer.
- Serum creatinine concentration that has peaked and has begun to improve (defined as a creatinine ≥0.30 mg/dL below the maximum serum creatinine concentration measured during the index hospitalization).
- Serum creatinine concentration that is no higher than 0.05 mg/dL higher on the day of randomization than compared to the most recent serum creatinine concentration ≥12 hours prior.
- A current creatinine-based eGFR ≥45 mL/min/1.73 m 2 (which, due to the stable- to-improving serum creatinine concentration requirements, as above, would indicate an eGFR that is truly ≥45 mL/min/1.73 m 2 ). eGFR ≥45 mL/min/1.73 m 2 is the most cautious eGFR threshold published among the three commercially available SGLT2i. 6,7
- A high likelihood, based on assessment of their medical chart, for discharge in the coming days with a plan to discharge to home without hospice services (meaning: not discharging to a rehabilitation facility or another hospital).
Who cannot join
- Vulnerable populations, including those with cognitive disorders (as noted in problem lists and active inpatient notes from the index hospitalization), pregnant patients, incarcerated patients, etc. will not be candidates for this study.
- If non-English speaking, a lack of available in-person interpreter within UMMC will be an exclusion criteria.
- A prior history of intolerance to a SGLT2i, as documented in the patient's allergy list and upon interviewing the candidate prior to randomization during the consenting process.
- If the candidate reports that they would object to taking a diuretic medication that, according to its mechanism of action, will increase their daily urinary volume, that will preclude study enrollment.
- Current treatment for a urinary tract infection of genital infection, defined by inpatient medical notes, or the candidate reporting a medical history of recurrent urinary tract infections will preclude study enrollment.
- Hypoglycemia, defined as a blood glucose concentration, \<60 mg/dL, during the hospitalization prior to randomization or the candidate reporting a medical history of recurrent hypoglycemia will preclude study enrollment.
- Both the consulting nephrology team and the primary inpatient team will be contacted before the patient is contacted, and they will be empowered to opt- out the patient if they do not think the patient is appropriate to receive a SGLT2i at this time. If Dr. Murphy is one of the staff physicians for the day for the candidate-patient, that patient will be excluded to avoid conflicts of interest or undue pressure on the patient. The patient can be one of Dr. Murphy's established outpatient or can be scheduled for AKI-nephrology follow-up after discharge with Dr. Murphy in the outpatient setting.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
SGLT2i have been shown to reduce risk for mortality, progression of chronic kidney disease, and cardiovascular outcomes in these populations. Yet, because SGLT2i can have an acute hemodynamic effect on kidney function, in clinical practice providers are wary of providing these medications to patients who have established indications but recently had acute kidney injury (AKI).
This is a pilot interventional study to collect process-data (measures of recruitment and measures of adherence) that can be used to establish feasibility for a larger pilot randomized trial in the future. The study aims to conduct a small randomized intervention trial with two arms, with approximately 10-12 patients in the intervention arm and 5-6 in the control arm. The intervention will be providing a prescription for a SGLT2i based on established criteria for this FDA-approved class of drugs, and the control will be usual care (through which, control arm participants will also have access to this FDA-approved class of drugs - expect receipt of a SGLT2i in the control arm to be rare, but a degree of crossover will be expected).
- Conditions
- Acute Kidney Injury
- Being tested
- SGLT2 inhibitor
- 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.
SGLT2 inhibitorDrug
a starting dose of a SGLT2i will be prescribed for the participant for pickup at discharge via the UMMC discharge pharmacy. The preferred prescription will be empagliflozin (Jardiance) 10mg daily with a 90-day fill and no refills, but this can be adjusted to other SGLT2i or other doses in the outpatient setting by either Dr. Murphy or by the participants' established providers, typically based on insurance company preferences among the three FDA-approved SGLT2i.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | usual care. no medication will be prescribed by Dr. Murphy. Only a basic metabolic panel lab test will be ordered in EPIC for the study participant to be done approximately 2 weeks after discharge and the results of which are to be routed to Dr. Murphy. A post-AKI / post-discharge basic metabolic panel lab test is a usual care lab test, and Dr. Murphy reviews such lab test results in his usual clinical practice. |
| Experimental group | Experimental | randomized to SGLT2i Receives: Drug: SGLT2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
SGLT2i use
proportion of patients in each arm of the study using a SGLT2i at one month of follow-up.
Measured: 1 month
Secondary outcomes (3)
number of participants who obtained follow-up basic metabolic panel
How many participants in each arm of the study obtain follow-up basic metabolic panel lab testing prior to the one-month (+/- 10 days) follow-up phone call.
Measured: 1 month
screening feasibility
How many patients we screen for every candidate we identify
Measured: 1 month
participation rate
How many candidate-patients we approach who enroll in the study as participants.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Apr 2024
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Why it stopped: Poor recruitment
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 University of MinnesotaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Murphy, MD, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124924
- Sponsor's protocol ID
- MED-2023-32227
- Status last verified
- Aug 2024
- First submitted
- 3 Nov 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT2 Inhibitors After Acute Kidney Injury With Indications Pilot
- ClinicalTrials.gov ID
- NCT06124924
- Acronym / sponsor ID
- MED-2023-32227
- Conditions
- Acute Kidney Injury
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 9 Nov 2023 (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.
SGLT2i have been shown to reduce risk for mortality, progression of chronic kidney disease, and cardiovascular outcomes in these populations. Yet, because SGLT2i can have an acute hemodynamic effect on kidney function, in clinical practice providers are wary of providing these medications to patients who have established indications but recently had acute kidney injury (AKI).
This is a pilot interventional study to collect process-data (measures of recruitment and measures of adherence) that can be used to establish feasibility for a larger pilot randomized trial in the future. The study aims to conduct a small randomized intervention trial with two arms, with approximately 10-12 patients in the intervention arm and 5-6 in the control arm. The intervention will be providing a prescription for a SGLT2i based on established criteria for this FDA-approved class of drugs, and the control will be usual care (through which, control arm participants will also have access to this FDA-approved class of drugs - expect receipt of a SGLT2i in the control arm to be rare, but a degree of crossover will be expected).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –usual care. no medication will be prescribed by Dr. Murphy. Only a basic metabolic panel lab test will be ordered in EPIC for the study participant to be done approximately 2 weeks after discharge and the results of which are to be routed to Dr. Murphy. A post-AKI / post-discharge basic metabolic panel lab test is a usual care lab test, and Dr. Murphy reviews such lab test results in his usual clinical practice. |
| Experimental group | Experimental | Drug: SGLT2 inhibitorrandomized to SGLT2i |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes mellitus, as indicated by review of the candidate's chart, as confirmed by interviewing the participant prior to randomization as part of the consent process, and documentation of at least one non-insulin diabetes medication that are specific to type 2 diabetes mellitus (with concurrent insulin use allowed) based on outpatient medication reconciliation documented in the inpatient medical notes and medication tab of Epic. SGLT2i are considered first- line therapy for type 2 diabetes mellitus.
- Age 40 to 75 years at time of screening. This age range is chosen to decrease the likelihood of pregnancy while also increasing the likelihood of participants having adequate life expectancy to benefit from SGLT2i use.
- No positive pregnancy test results during the current hospitalization (or from a transferring hospital or transferring emergency room) or documentation in the electronic medical chart of an existing pregnancy. For candidates for the study who are female of childbearing age \<55 years (an approximate upper limit for menopause) with a urine sample in the UMMC laboratory available to add-on a urine pregnancy test, Dr. Murphy will ask the primary team or nephrology team to add-on that test if medical relevant (pregnancy is virtually always medically relevant). If they cannot (because no urine sample is available or they determine it is not medically relevant), that patient will no longer be considered a study- candidate.
- AKI occurring during the index hospitalization or present-on-admission, with a nephrology consult active after the onset of the AKI. The nephrology consult team need not be active at the time of study enrollment, though, if not medically needed any longer.
- Serum creatinine concentration that has peaked and has begun to improve (defined as a creatinine ≥0.30 mg/dL below the maximum serum creatinine concentration measured during the index hospitalization).
Key exclusion criteria (7 listed)
- Vulnerable populations, including those with cognitive disorders (as noted in problem lists and active inpatient notes from the index hospitalization), pregnant patients, incarcerated patients, etc. will not be candidates for this study.
- If non-English speaking, a lack of available in-person interpreter within UMMC will be an exclusion criteria.
- A prior history of intolerance to a SGLT2i, as documented in the patient's allergy list and upon interviewing the candidate prior to randomization during the consenting process.
- If the candidate reports that they would object to taking a diuretic medication that, according to its mechanism of action, will increase their daily urinary volume, that will preclude study enrollment.
- Current treatment for a urinary tract infection of genital infection, defined by inpatient medical notes, or the candidate reporting a medical history of recurrent urinary tract infections will preclude study enrollment.
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 |
|---|---|---|
| SGLT2 inhibitora starting dose of a SGLT2i will be prescribed for the participant for pickup at discharge via the UMMC discharge pharmacy. The preferred prescription will be empagliflozin (Jardiance) 10mg daily with a 90-day fill and no refills, but this can be adjusted to other SGLT2i or other doses in the outpatient setting by either Dr. Murphy or by the participants' established providers, typically based on insurance company preferences among the three FDA-approved SGLT2i. | Drug | Experimental group |
Primary outcome
SGLT2i use
Time frame: 1 month
proportion of patients in each arm of the study using a SGLT2i at one month of follow-up.
3 secondary outcomes
number of participants who obtained follow-up basic metabolic panel
Time frame: 1 month
screening feasibility
Time frame: 1 month
participation rate
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
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
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
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. This study is not recruiting at the moment.
Daniel Murphy, MD, MS principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SGLT2 inhibitor in people with Acute Kidney Injury, run by University of Minnesota at 1 site 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SGLT2i use (time frame: 1 month). 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 23 Aug 2024.