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

Sponsor
Tanta University
Study ID
NCT05373680
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Renal Insufficiency, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    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).
  • Empagliflozin — DRUG
    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).
  • Control — OTHER
    Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).

Study Details

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.

Key Dates

Start date
Jan 1, 2022
Status verified
Apr 2023
Primary completion
Apr 1, 2024
Completion
Apr 1, 2024

Study Design

Enrollment
118 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Other: Control group
    In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive their usual therapy.

Primary Outcome Measure

Change in estimated glomerular filtration rate (eGFR) values from baseline [ Time Frame: Period of 12 months ]

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