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Metformin vs Empagliflozin for CKD Progression
NCT05373680Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2022
- Primary completion
- Apr 2024
- Countries
- 1
- Sponsor
- Tanta University
- Modality
- Small Molecules
- Conditions
- chronic kidney disease (CKD)
01
Overview
Phase 3, randomised, open-label trial of liquid metformin (Aspargo Labs) and empagliflozin in chronic kidney disease (CKD) (3 arms), sponsored by Tanta University. Primary endpoint: Change in estimated glomerular filtration rate values from baseline at 12 months. Started Jan 2022; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Metformin
Metformin 1000 mg PO daily + usual therapy
Empagliflozin
Empagliflozin 10 mg PO daily + usual therapy
Control
Usual therapy
03
Who it enrols
Patients with mild to moderate CKD (eGFR 30-89), with or without type 2 diabetes. Excludes type 1 diabetes, eGFR <30, hepatic failure, and prior use of study medications.
04
Endpoints
Primary
Change in estimated glomerular filtration rate values from baseline
Secondary
Change in albumin or protein excretion values from baseline
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