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

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Drug: Metformin
* Drug: Empagliflozin
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin treatment group<br>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<br>* 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).<br>* Other names: Biguanide;Other: Control<br>* Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).<br>|
| Experimental: Empagliflozin treatment group<br>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<br>* 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).<br>* Other names: Sodium glucose cotransporter-2 (SGLT2) inhibitor;Other: Control<br>* Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).<br>|
| Other: Control group<br>In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive their usual therapy. | Other: Control<br>* Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metformin, Empagliflozin, Chronic kidney disease