Overview
SGLT2 Inhibitors After Acute Kidney Injury With Indications Pilot
Status:
Recruiting
Recruiting
Trial end date:
2025-05-30
2025-05-30
Target enrollment:
0
0
Participant gender:
All
All
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 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).Phase:
Early Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of MinnesotaTreatments:
Sodium-Glucose Transporter 2 Inhibitors
Criteria
Inclusion Criteria:- 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).
Exclusion Criteria:
- 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.