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SGLT2 Inhibitors Prophylaxis Against Post-contrast Acute Kidney Injury in Diabetic Kidney Disease?

Is SGLT2 Inhibitors a Better Prophylactic Agent Against Post-contrast Acute Kidney Injury in Diabetic Kidney Disease? A Multicenter Prospective Randomized Controlled Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04853615
Enrollment
800
Registered
2021-04-21
Start date
2021-07-01
Completion date
2024-08-01
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SGLT2i Kideny Protection Against Contrast in Diabetic Kidney

Brief summary

We will look for the possible effect of SGLT2i as a single agent to prevent post-contrast Acute Kidney Injury in diabetic kidney disease.

Detailed description

Population of Study o Group 1 : 1. st group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast. o Group 2 : 2. nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily o Group 3 : 3. rd group will receive the SGLT2i empagliflosin 25 mg once daily o Group 4 : 4. thwill receive allopurinol and empagliflosin. Inclusion Criteria : o Age: more than30years, diabetes,diabetic kidney disease,GFR: more than30ml/min/1.73m2 Exclusion Criteria : o Diabetics Patients with GFR less than 30 mL/min/1.73 m2. Sample Size ( number of participants included ) : 800 patients Fayoum University Faculty of Medicine Scientific Research Ethics Committee Methodology in details : The chosen patients will be randomly allocated to 4 equal groups that will receive their prophylaxis for 48 hours before and 48 hours after the radiocontrast administration. Baseline serum creatinine will be obtained 72 hours before the planned intervention and before administration of any protective protocol and follow-up serum creatinine will be obtained 72 hours and 1 week after contrast administration. The first control group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast. Saline should be given by infusion pump to guarantee steady rate of infusion. 2nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily. 3rd group will receive the SGLT2i empagliflosin 25 mg once daily, and the 4th will receive allopurinol and empagliflosin.

Interventions

DRUGEmpagliflozin 25 MG

PAtient will receive empagliflozin 25 mg daily

Sponsors

Cairo University
CollaboratorOTHER
Fayoum University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age: more than30years, Diabetes, Diabetic kidney disease, GFR: more than30ml/min/1.73m2

Exclusion criteria

* Diabetics Patients with GFR less than 30 mL/min/1.73 m2.

Design outcomes

Primary

MeasureTime frameDescription
SGLT2i proves protective effect72hours after contrastSGLT2i shows protected the kidneys against contrast injury

Secondary

MeasureTime frameDescription
SGLT2i is non inferior to allopurinol72hours after contrastSGLT2i showed noninferiorty whencompared to allopurinol

Contacts

Primary ContactAhmed A Hammad, MD
aah12@fayoum.edu.eg+201001574639
Backup ContactAhmed Fayed, MD
dr.fayed@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026