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

Overview

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.

Full Title of Study: “Clinical Study Evaluating the Efficacy and Safety of Metformin Versus Empagliflozin for Halting Chronic Kidney Disease Progression”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2024

Interventions

  • Drug: 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).
  • Drug: 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).
  • Other: Standard therapy
    • Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • Change in albumin or protein excretion values from baseline
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tanta University
  • Collaborator
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bassant Maher Mahboub, Principal Investigator: Bassant Maher Abbas Mahboub, PhD candidate. – Tanta University

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