Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06124924
Status:
TERMINATED
Last Update Posted:
2024-05-03
First Post:
2023-11-03
Brief Title:
SGLT2 Inhibitors After Acute Kidney Injury With Indications Pilot
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
SGLT2 Inhibitors After Acute Kidney Injury With Indications Pilot
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None