Renal Insufficiency, Chronic
Conditions
Keywords
Metformin, Empagliflozin, Chronic kidney disease
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.
Interventions
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).
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).
Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt