Efficacy and Safety of Metformin Versus Empagliflozin on Chronic Kidney Disease Progression

Renal Insufficiency, Chronic Clinical Trial

Official title:

Clinical Study Evaluating the Efficacy and Safety of Metformin Versus Empagliflozin for Halting Chronic Kidney Disease Progression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05373680
• Other study ID #: 34976/10/21
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2022
• Est. completion date: June 2024

Study information

• Verified date: April 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial aims at evaluating the efficacy and safety of the antidiabetics metformin versus empagliflozin on chronic kidney disease (CKD) progression in patients with CKD stages 2 or/and 3.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with mild or/and moderate chronic kidney disease (stages 2 or/and 3, estimated glomerular filtration rate (eGFR) between 30-89 ml/min/1.73 m2) at the time of the baseline visit.

• Patients with and without type 2 diabetes.

• Patients with or without proteinuria.

• Age: = 18 years.

Exclusion Criteria:

• Type 1 diabetes.

• Patients with eGFR ?30 ml/min/1.73 m2.

• Patients with known hepatic cell failure.

• Decompensated heart requiring acute management.

• Active malignancy.

• Planned coronary or surgical interventions.

• Known hypersensitivity to study medications.

• Chronic inflammation, trauma, or infection.

• Pregnant or lactating women.

• Patients already on metformin or a sodium-glucose cotransporter-2 (SGLT2) inhibitor.

• Any of the study treatments labeled contraindications.

Related Conditions & MeSH terms

• Disease Progression
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Metformin
Patients will receive metformin 1000 mg PO daily added to their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).
• Empagliflozin
Patients will receive empagliflozin 10 mg daily PO added to their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).

Other:
• Control
Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dakahlia Governorate
Egypt	Tanta University Teaching Hospitals	Tanta	Gharbia Governorate

Sponsors (2)

Lead Sponsor	Collaborator
Tanta University	Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in estimated glomerular filtration rate (eGFR) values from baseline	This will be achieved by measuring the serum creatinine levels and then eGFR values will be calculated.	Period of 12 months
Primary	Change in albumin or protein excretion values from baseline	This will be achieved by measuring the urinary albumin or protein:creatinine ratio from a spot urine test in a morning sample.	Period of 12 months