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Completed

NCT Number: NCT05373680

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

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.

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mansoura University, Al Mansurah, Dakahlia Governorate, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Biguanide

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).

Other names: Sodium glucose cotransporter-2 (SGLT2) inhibitor

Control

Other

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

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

  • Mansoura University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 13, 2022
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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