Clinical Study Evaluating the Efficacy and Safety of Metformin Versus Empagliflozin for Halting Chronic Kidney Disease Progression
Overview
- Phase
- Phase 2
- Intervention
- Metformin
- Conditions
- Renal Insufficiency, Chronic
- Sponsor
- Tanta University
- Enrollment
- 118
- Locations
- 2
- Primary Endpoint
- Change in estimated glomerular filtration rate (eGFR) values from baseline
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Bassant Maher Mahboub
Principal Investigator: Bassant Maher Abbas Mahboub, PhD candidate.
Tanta University
Eligibility Criteria
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 m
- •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.
Arms & Interventions
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.
Intervention: Metformin
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.
Intervention: Control
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.
Intervention: Empagliflozin
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.
Intervention: Control
Control group
In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive their usual therapy.
Intervention: Control
Outcomes
Primary Outcomes
Change in estimated glomerular filtration rate (eGFR) values from baseline
Time Frame: Period of 12 months
This will be achieved by measuring the serum creatinine levels and then eGFR values will be calculated.
Secondary Outcomes
- Change in albumin or protein excretion values from baseline(Period of 12 months)