Renal Insufficiency, ChronicPhase 2/3NCT05373680
Efficacy and Safety of Metformin Versus Empagliflozin on Chronic Kidney Disease Progression
A Phase 2/3 study testing Metformin and Empagliflozin in people with Renal Insufficiency, Chronic, run by Tanta University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Metformin and Empagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2022to 1 Apr 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Mansoura University
Al Mansurah, Dakahlia Governorate
Tanta University Teaching Hospitals
Tanta, Gharbia Governorate
About this study
Official title: Clinical Study Evaluating the Efficacy and Safety of Metformin Versus Empagliflozin for Halting 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.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Metformin, Empagliflozin, Control
- Keywords
- Metformin, Empagliflozin, Chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Biguanide
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).
EmpagliflozinDrug
Also called Sodium glucose cotransporter-2 (SGLT2) inhibitor
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).
ControlOther
Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).
| Study group | Role | What they receive |
|---|---|---|
| Metformin treatment group | Experimental | 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. Receives: Drug: Metformin; Other: Control |
| Empagliflozin treatment group | Experimental | 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. Receives: Drug: Empagliflozin; Other: Control |
| Control group | Other | In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive their usual therapy. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Period of 12 months
Secondary outcomes (1)
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.
Measured: Period of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start1 Jan 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Bassant Maher Mahboub, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373680
- Sponsor's protocol ID
- 34976/10/21
- Status last verified
- Apr 2023
- First submitted
- 18 Feb 2022
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mahboub BM, Refaie AF, El-Haggar SM, Hafez YM, Mostafa TM. Efficacy and safety of metformin versus empagliflozin on chronic kidney disease progression (MET-EMPA-CKD): a randomized controlled trial. Diabetol Metab Syndr. 2025 Dec 10;18(1):17. doi: 10.1186/s13098-025-02040-9.
PubMed 41373013El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.
PubMed 38837240
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy and Safety of Metformin Versus Empagliflozin for Halting Chronic Kidney Disease Progression
- ClinicalTrials.gov ID
- NCT05373680
- Acronym / sponsor ID
- 34976/10/21
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Metformin, Empagliflozin, Chronic kidney disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin treatment group | Experimental | Drug: Metformin, Other: ControlIn this arm, patients with chronic kidney disease who meet study inclusion criteria will receive metformin 1000 mg PO daily added to their usual therapy. |
| Empagliflozin treatment group | Experimental | Drug: Empagliflozin, Other: ControlIn this arm, patients with chronic kidney disease who meet study inclusion criteria will receive empagliflozin 10 mg daily PO added to their usual therapy. |
| Control group | Other | Other: ControlIn this arm, patients with chronic kidney disease who meet study inclusion criteria will receive their usual therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: BiguanidePatients 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 | Metformin treatment group |
| EmpagliflozinAlso: Sodium glucose cotransporter-2 (SGLT2) inhibitorPatients 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). | Drug | Empagliflozin treatment group |
| ControlPatients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care). | Other | Control group, Empagliflozin treatment group, Metformin treatment group |
Primary outcome
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.
1 secondary outcome
Change in albumin or protein excretion values from baseline
Time frame: Period of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Derived from this study: PubMed 41373013Mahboub BM, Refaie AF, El-Haggar SM, Hafez YM, Mostafa TM. Efficacy and safety of metformin versus empagliflozin on chronic kidney disease progression (MET-EMPA-CKD): a randomized controlled trial. Diabetol Metab Syndr. 2025 Dec 10;18(1):17. doi: 10.1186/s13098-025-02040-9.
- Derived from this study: PubMed 38837240El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Metformin and Empagliflozin in people with Renal Insufficiency, Chronic, run by Tanta University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in estimated glomerular filtration rate (eGFR) values from baseline (time frame: Period of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05373680, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.