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Clinical trial

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

ID
Name
34976/10/21
Description
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.
Trial arms
Trial start
2022-01-01
Estimated PCD
2024-01-01
Trial end
2024-06-01
Status
Recruiting
Phase
Early phase I
Treatment
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).
Arms:
Metformin treatment group
Other names:
Biguanide
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).
Arms:
Empagliflozin treatment group
Other names:
Sodium glucose cotransporter-2 (SGLT2) inhibitor
Control
Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).
Arms:
Control group, Empagliflozin treatment group, Metformin treatment group
Size
90
Primary endpoint
Change in estimated glomerular filtration rate (eGFR) values from baseline
Period of 12 months
Change in albumin or protein excretion values from baseline
Period of 12 months
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 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2023-04-18

1 organization

1 product

1 drug

2 indications

Organization
Tanta University
Drug
Metformin
Indication
Chronic Kidney Disease
Indication
Chronic
Product
Empagliflozin