Sodium Glucose Co-Transporter 2 InhibitorsNCT07302464
Sodium Glucose Co-Transporter 2 Inhibitors on Estimated Glomerular Filtration Rate in Diabetic Versus Non-Diabetic Chronic Kidney Disease Patients
An observational study of Sodium Glucose Co-Transporter 2 Inhibitors and Estimated Glomerular Filtration Rate, run by Ain Shams University at 1 site in Egypt.
Trial summary
The work aimed to compare the effects of Sodium-glucose co-transporter-2 (SGLT2) inhibitors on glomerular filtration rate (GFR) in patients with diabetic chronic kidney disease (CKD) and non-diabetic CKD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sodium Glucose Co-Transporter 2 Inhibitors, Estimated Glomerular Filtration Rate, Diabetes
- What is being tested?
- Sodium Glucose Co-Transporter 2 Inhibitors
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Jun 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This case-control study was done on 60 adult chronic kidney disease (CKD) individuals with stage 3 and 4 (eGFR>_20ml/min/1.73 m2) according to KIDGO classification at Ain Shams University Hospitals, Cairo, Egypt.
Who may be able to join
- Age ≥ 18 years.
- Both sexes.
- Chronic kidney disease (CKD) participants with stages 3 and 4.
Who cannot join
- Patients with type 1 diabetes mellitus (DM).
- Patients with decompensated Chronic liver disease.
- Patients with uncontrolled hypertension.
- Patients with blood pressure (BP) > 110/70.
- Patients already on the same medication (Sodium Glucose Co-Transporter 2 Inhibitors).
- Patients with a history of recurrent or recent urinary tract infection (UTI).
Show all 9Show fewer
- Patients with glycated hemoglobin (HbA1c) ≤10.
- Adult polycystic kidney disease.
- All patients on immunosuppressive medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sodium Glucose Co-Transporter 2 Inhibitors on Estimated Glomerular Filtration Rate in Diabetic Versus Non-Diabetic Chronic Kidney Disease Patients
The work aimed to compare the effects of Sodium-glucose co-transporter-2 (SGLT2) inhibitors on glomerular filtration rate (GFR) in patients with diabetic chronic kidney disease (CKD) and non-diabetic CKD.
Read the detailed description
Glucose reabsorption is mediated by the sodium-glucose cotransporter (SGLT) 2, which reabsorbs 90% of glucose, and SGLT1, which reabsorbs the remaining 10%.
The relationship between hyperglycaemia and the development of renal disease is complex. Hyperglycaemia-induced complications are mediated by several metabolic pathways, among which accumulation of Advanced Glycation End-products with abnormalities of the glycosylation of macromolecules and increased glucose flux through the polyol pathway seem to be the most important.
- Conditions
- Sodium Glucose Co-Transporter 2 Inhibitors, Estimated Glomerular Filtration Rate, Diabetes, Chronic Kidney Disease
- Being tested
- Sodium Glucose Co-Transporter 2 Inhibitors
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Glucose Co-Transporter 2 InhibitorsOther
All candidates start therapy with sodium glucose co-transporter 2 (SGLT2) inhibitors with a dose of 10mg daily Dapagliflozin for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Study group | Chronic kidney disease (CKD) participants with type 2 diabetes mellitus (T2DM) Receives: Other: Sodium Glucose Co-Transporter 2 Inhibitors | |
| Control group | Chronic kidney disease (CKD) participants without diabetes mellitus Receives: Other: Sodium Glucose Co-Transporter 2 Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the estimated glomerular filtration rate
Change in the estimated glomerular filtration rate (eGFR) was recorded.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Oct 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium Glucose Co-Transporter 2 InhibitorsStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Hassan, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302464
- Sponsor's protocol ID
- FMASU MS 603/2024
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Glucose Co-Transporter 2 Inhibitors on Estimated Glomerular Filtration Rate in Diabetic Versus Non-Diabetic Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT07302464
- Acronym / sponsor ID
- FMASU MS 603/2024
- Conditions
- Sodium Glucose Co-Transporter 2 Inhibitors, Estimated Glomerular Filtration Rate, Diabetes, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 24 Dec 2025 (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.
The work aimed to compare the effects of Sodium-glucose co-transporter-2 (SGLT2) inhibitors on glomerular filtration rate (GFR) in patients with diabetic chronic kidney disease (CKD) and non-diabetic CKD.
Detailed description
Glucose reabsorption is mediated by the sodium-glucose cotransporter (SGLT) 2, which reabsorbs 90% of glucose, and SGLT1, which reabsorbs the remaining 10%.
The relationship between hyperglycaemia and the development of renal disease is complex. Hyperglycaemia-induced complications are mediated by several metabolic pathways, among which accumulation of Advanced Glycation End-products with abnormalities of the glycosylation of macromolecules and increased glucose flux through the polyol pathway seem to be the most important.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Sodium Glucose Co-Transporter 2 InhibitorsChronic kidney disease (CKD) participants with type 2 diabetes mellitus (T2DM) |
| Control group | – | Other: Sodium Glucose Co-Transporter 2 InhibitorsChronic kidney disease (CKD) participants without diabetes mellitus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This case-control study was done on 60 adult chronic kidney disease (CKD) individuals with stage 3 and 4 (eGFR>_20ml/min/1.73 m2) according to KIDGO classification at Ain Shams University Hospitals, Cairo, Egypt.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Both sexes.
- Chronic kidney disease (CKD) participants with stages 3 and 4.
Key exclusion criteria (9 listed)
- Patients with type 1 diabetes mellitus (DM).
- Patients with decompensated Chronic liver disease.
- Patients with uncontrolled hypertension.
- Patients with blood pressure (BP) > 110/70.
- Patients already on the same medication (Sodium Glucose Co-Transporter 2 Inhibitors).
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 |
|---|---|---|
| Sodium Glucose Co-Transporter 2 InhibitorsAll candidates start therapy with sodium glucose co-transporter 2 (SGLT2) inhibitors with a dose of 10mg daily Dapagliflozin for 6 months | Other | Control group, Study group |
Primary outcome
Change in the estimated glomerular filtration rate
Time frame: 6 months post-procedure
Change in the estimated glomerular filtration rate (eGFR) was recorded.
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 24 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sodium Glucose Co-Transporter 2 Inhibitors and Estimated Glomerular Filtration Rate, run by Ain Shams University at 1 site 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 3 inclusion and 9 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 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 the estimated glomerular filtration rate (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.