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

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

Study Overview

• Status: Not yet recruiting
• Conditions: SGLT2i Kideny Protection Against Contrast in Diabetic Kidney
• Intervention / Treatment: Drug: Empagliflozin 25 MG

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.

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Ahmed A Hammad, MD; Phone Number: +201001574639; Email: aah12@fayoum.edu.eg
• Study Contact Backup: Name: Ahmed Fayed, MD; Email: dr.fayed@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; 1st group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast
Group 2; 2nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily
Group 3; 3rd group will receive the SGLT2i empagliflosin 25 mg once daily	Drug: Empagliflozin 25 MG; PAtient will receive empagliflozin 25 mg daily; Other Names: SGLT2 inhibitors
Group 4; 4thwill receive allopurinol and empagliflosin.	Drug: Empagliflozin 25 MG; PAtient will receive empagliflozin 25 mg daily; Other Names: SGLT2 inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SGLT2i proves protective effect	SGLT2i shows protected the kidneys against contrast injury	72hours after contrast

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SGLT2i is non inferior to allopurinol	SGLT2i showed noninferiorty whencompared to allopurinol	72hours after contrast

Collaborators and Investigators

• Sponsor: Fayoum University
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: April 17, 2021
• First Submitted That Met QC Criteria: April 17, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Renal Insufficiency; Kidney Diseases; Diabetic Nephropathies; Acute Kidney Injury; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Empagliflozin; Sodium-Glucose Transporter 2 Inhibitors
• Other Study ID Numbers: EC 2119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No