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

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05373680

Collaborator

Mansoura University (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency, Chronic	Drug: Metformin Drug: Empagliflozin Other: Standard therapy	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metformin treatment group In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive metformin 1000 mg PO daily added to their usual therapy.	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). Other Names: Biguanide Other: Standard therapy Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).
Experimental: Empagliflozin treatment group In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive empagliflozin 10 mg daily PO added to their usual therapy.	Drug: 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 Names: Sodium glucose cotransporter-2 (SGLT2) inhibitor Other: Standard therapy Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).
Other: Control group In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive their usual therapy.	Other: Standard therapy Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).

Arm

Intervention/Treatment

Experimental: Metformin treatment group

In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive metformin 1000 mg PO daily added to their usual therapy.

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).

Other Names:

Biguanide

Other: Standard therapy

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

Experimental: Empagliflozin treatment group

In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive empagliflozin 10 mg daily PO added to their usual therapy.

Drug: 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 Names:

Sodium glucose cotransporter-2 (SGLT2) inhibitor

Other: Standard therapy

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

Other: Control group

In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive their usual therapy.

Other: Standard therapy

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.