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SGLT2 Inhibitors After Acute Kidney Injury With Indications Pilot

NCT06124924 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-08-23

No results posted yet for this study

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).

Conditions

Interventions

DRUG

SGLT2 inhibitor

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.

Sponsors & Collaborators

Principal Investigators

  • Daniel Murphy, MD, MS · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-08-16
Completion
2024-08-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06124924 on ClinicalTrials.gov