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

Primary Purpose

Renal Insufficiency, Chronic

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Metformin
Empagliflozin
Control
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring Metformin, Empagliflozin, Chronic kidney disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura UniversityRecruiting
  • Tanta University Teaching HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Metformin treatment group

Empagliflozin treatment group

Control group

Arm Description

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.

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.

In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive their usual therapy.

Outcomes

Primary Outcome Measures

Change in estimated glomerular filtration rate (eGFR) values from baseline
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
This will be achieved by measuring the urinary albumin or protein:creatinine ratio from a spot urine test in a morning sample.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2022
Last Updated
April 12, 2023
Sponsor
Tanta University
Collaborators
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05373680
Brief Title
Efficacy and Safety of Metformin Versus Empagliflozin on Chronic Kidney Disease Progression
Official Title
Clinical Study Evaluating the Efficacy and Safety of Metformin Versus Empagliflozin for Halting Chronic Kidney Disease Progression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
Collaborators
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
Keywords
Metformin, Empagliflozin, Chronic kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Empagliflozin treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive their usual therapy.
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Biguanide
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Other Intervention Name(s)
Sodium glucose cotransporter-2 (SGLT2) inhibitor
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).
Primary Outcome Measure Information:
Title
Change in estimated glomerular filtration rate (eGFR) values from baseline
Description
This will be achieved by measuring the serum creatinine levels and then eGFR values will be calculated.
Time Frame
Period of 12 months
Title
Change in albumin or protein excretion values from baseline
Description
This will be achieved by measuring the urinary albumin or protein:creatinine ratio from a spot urine test in a morning sample.
Time Frame
Period of 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
Dakahlia Governorate
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassant Mahboub, M.Sc.
Phone
Dr.
Email
bassantm.mahboub@gmail.com
Facility Name
Tanta University Teaching Hospitals
City
Tanta
State/Province
Gharbia Governorate
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassant Mahboub, M.Sc.
Phone
Dr.
Email
bassantm.mahboub@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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