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
About this trial
This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring Metformin, Empagliflozin, Chronic kidney disease
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.
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
NCT ID
NCT05373680
First Posted
February 18, 2022
Last Updated
April 12, 2023
Sponsor
Tanta University
Collaborators
Mansoura University
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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