Chronic Kidney DiseasePhase 3NCT07344922
SGLT2 Inhibitors in Non-Diabetic CKD: Effects on Vascular Calcification and Anemia
A Phase 3 study testing Dapagliflozin (10Mg Tab) along with standard medical therapy in people with Chronic Kidney Disease and Anemia, run by Mansoura University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if the drug dapagliflozin (an SGLT2 inhibitor) can help protect the kidneys, improve anemia, and support heart health in adults with chronic kidney disease (CKD) who do not have diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Anemia, Cardiovascular Calcification
- What is being tested?
- Dapagliflozin (10Mg Tab) along with standard medical therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Dec 2023
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years with a diagnosis of chronic kidney disease (CKD), non-diabetic etiology.
- Estimated glomerular filtration rate (eGFR) between 20 and 60 mL/min/1.73 m² at screening.
- Stable standard CKD care for at least 3 months prior to enrollment.
- Ability to provide written informed consent.
Who cannot join
- Diagnosis of diabetes mellitus (type 1 or type 2).
- History of kidney transplantation or currently on dialysis.
- Acute kidney injury within the past 3 months.
- Known hypersensitivity to dapagliflozin or excipients.
- Pregnant or breastfeeding women.
- Participation in another interventional clinical trial within the past 30 days.
- Severe uncontrolled cardiovascular disease (e.g., recent myocardial infarction, unstable angina, decompensated heart failure).
- Any condition judged by the investigator to interfere with study participation or interpretation of results.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and Nephrology Center, Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Impact of Sodium-Glucose Co-transporter 2 Inhibitors on Cardiovascular System and Anemia in Non-diabetic Chronic Kidney Disease Patients. A Randomized-Controlled Clinical Trial
The goal of this clinical trial is to learn if the drug dapagliflozin (an SGLT2 inhibitor) can help protect the kidneys, improve anemia, and support heart health in adults with chronic kidney disease (CKD) who do not have diabetes. The main questions it aims to answer are:
Does dapagliflozin slow the worsening of kidney function compared to standard care?
Read more
Does dapagliflozin improve anemia by increasing hemoglobin and related blood markers?
Does dapagliflozin improve heart function and reduce cardiovascular problems in CKD patients?
Researchers will compare dapagliflozin to a placebo (a look-alike pill with no active drug) to see if dapagliflozin works better than standard treatment alone.
Participants will:
Take dapagliflozin or a placebo once daily for 12 months, along with their usual CKD medications.
Visit the clinic every 3 months for checkups, blood tests, urine tests, and heart evaluations.
Have measurements of kidney function, anemia markers, and heart health taken at baseline and during follow-up visits.
Read the detailed description
Chronic kidney disease (CKD) is a serious health problem that affects millions of people worldwide. It often leads to worsening kidney function, anemia (low blood count), and heart problems. While diabetes is a common cause of CKD, many patients develop kidney disease without having diabetes. These patients still face high risks of anemia and cardiovascular complications, but treatment options remain limited.
Dapagliflozin, a medicine from the sodium-glucose co-transporter 2 (SGLT2) inhibitor family, was originally developed to lower blood sugar in people with diabetes. However, recent large studies have shown that dapagliflozin can also protect the kidneys and improve heart health-even in patients who do not have diabetes. There is also evidence that this drug may help improve anemia by boosting the body's ability to make red blood cells.
This study is designed to test whether dapagliflozin can provide these benefits in adults with CKD who do not have diabetes. The trial will compare dapagliflozin to a placebo (a pill with no active drug) alongside standard medical care.
Key goals of the study are to learn:
Whether dapagliflozin slows the decline of kidney function.
Whether it improves anemia by increasing hemoglobin and related blood markers.
Whether it improves heart health, including heart function and blood vessel changes.
How safe dapagliflozin is for patients with CKD who do not have diabetes.
How the study works:
About 100 adults with CKD will take part.
Participants will be randomly assigned to receive either dapagliflozin or a placebo, in addition to their usual medications.
The treatment will last for 12 months.
Participants will visit the clinic every 3 months for checkups, blood and urine tests, and heart evaluations such as echocardiography and ECG.
At the end of the study, researchers will compare kidney function, anemia markers, and heart health between the two groups.
Why this study matters: If dapagliflozin proves effective, it could become an important new option for patients with CKD who do not have diabetes. This would mean better kidney outcomes, fewer complications from anemia, and improved heart health for a large group of patients who currently have limited treatment choices.
- Conditions
- Chronic Kidney Disease, Anemia, Cardiovascular Calcification
- Being tested
- Dapagliflozin (10Mg Tab) along with standard medical therapy, Placebo
- Keywords
- dapagliflozin, Anemia, vascular calcification
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (10Mg Tab) along with standard medical therapyDrug
Participants will receive dapagliflozin 10 mg oral tablet once daily, with or without food, in addition to standard chronic kidney disease care. Treatment will continue for 12 months.
PlaceboOther
Participants will receive a placebo oral tablet once daily, identical in appearance to dapagliflozin but containing no active drug, in addition to standard chronic kidney disease care. Treatment will continue for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Participants receive dapagliflozin 10 mg once daily plus standard CKD care. Receives: Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy |
| Placebo | Placebo comparator | Participants receive placebo once daily plus standard CKD care Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of sustained decline in kidney function or progression to end-stage kidney disease
Composite outcome defined as ≥50% sustained decline in estimated glomerular filtration rate (eGFR) from baseline or reaching end-stage kidney disease requiring dialysis or transplantation.
Measured: 12 months
Secondary outcomes (6)
Change in Hemoglobin
Change from baseline in hemoglobin levels (g/dL).
Measured: 12 months
Change in Serum Hepcidin
Change from baseline in serum hepcidin levels (ng/mL).
Measured: 12 months
Change in Erythropoietin (EPO)
Change from baseline in erythropoietin levels (mIU/mL).
Measured: 12 months
Change in Left Ventricular Ejection Fraction (LVEF)
Change from baseline in LVEF assessed by echocardiography (percentage).
Measured: 12 month
Change in Coronary Artery Calcium Score
Change from baseline in coronary artery calcium score (Agatston score).
Measured: 12 month
Incidence of Major Adverse Cardiovascular Events (MACE)
Number of participants with at least one Major Adverse Cardiovascular Event, defined as a composite of: myocardial infarction, stroke, or hospitalization for heart failure (Participants).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Sep 2022
- Primary completion1 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Mansoura 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-arm, parallel assignment clinical trial. A total of 100 adults with non-diabetic chronic kidney disease (CKD) will be enrolled and randomly assigned in equal numbers to one of two groups: Intervention group: Participants will receive dapagliflozin 10 mg once daily in addition to standard CKD care. Control group: Participants will receive a placebo once daily in addition to standard CKD care. Both groups will be followed in parallel for 12 months. Outcomes related to kidney function, anemia, and cardiovascular health will be compared between the two groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Gamal Mosad Abu-Gharbia, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344922
- Sponsor's protocol ID
- MS.22.04.1973
- Status last verified
- Jan 2026
- First submitted
- 14 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because of privacy concerns, regulatory restrictions, and the absence of a formal data-sharing infrastructure at the study site. De-identified aggregate results will be published, but raw participant-level data will not be made available to protect confidentiality.
Publications
Oshima M, Neuen BL, Jardine MJ, Bakris G, Edwards R, Levin A, Mahaffey KW, Neal B, Pollock C, Rosenthal N, Wada T, Wheeler DC, Perkovic V, Heerspink HJL. Effects of canagliflozin on anaemia in patients with type 2 diabetes and chronic kidney disease: a post-hoc analysis from the CREDENCE trial. Lancet Diabetes Endocrinol. 2020 Nov;8(11):903-914. doi: 10.1016/S2213-8587(20)30300-4.
PubMed 33065060Ghanim H, Abuaysheh S, Hejna J, Green K, Batra M, Makdissi A, Chaudhuri A, Dandona P. Dapagliflozin Suppresses Hepcidin And Increases Erythropoiesis. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgaa057. doi: 10.1210/clinem/dgaa057.
PubMed 32044999Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.
PubMed 32970396
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sodium-Glucose Co-transporter 2 Inhibitors on Cardiovascular System and Anemia in Non-diabetic Chronic Kidney Disease Patients. A Randomized-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07344922
- Acronym / sponsor ID
- MS.22.04.1973
- Conditions
- Chronic Kidney Disease, Anemia, Cardiovascular Calcification
- Keywords
- dapagliflozin, Anemia, vascular calcification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 15 Jan 2026 (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 goal of this clinical trial is to learn if the drug dapagliflozin (an SGLT2 inhibitor) can help protect the kidneys, improve anemia, and support heart health in adults with chronic kidney disease (CKD) who do not have diabetes. The main questions it aims to answer are:
Does dapagliflozin slow the worsening of kidney function compared to standard care?
Does dapagliflozin improve anemia by increasing hemoglobin and related blood markers?
Does dapagliflozin improve heart function and reduce cardiovascular problems in CKD patients?
Researchers will compare dapagliflozin to a placebo (a look-alike pill with no active drug) to see if dapagliflozin works better than standard treatment alone.
Participants will:
Take dapagliflozin or a placebo once daily for 12 months, along with their usual CKD medications.
Visit the clinic every 3 months for checkups, blood tests, urine tests, and heart evaluations.
Have measurements of kidney function, anemia markers, and heart health taken at baseline and during follow-up visits.
Detailed description
Chronic kidney disease (CKD) is a serious health problem that affects millions of people worldwide. It often leads to worsening kidney function, anemia (low blood count), and heart problems. While diabetes is a common cause of CKD, many patients develop kidney disease without having diabetes. These patients still face high risks of anemia and cardiovascular complications, but treatment options remain limited.
Dapagliflozin, a medicine from the sodium-glucose co-transporter 2 (SGLT2) inhibitor family, was originally developed to lower blood sugar in people with diabetes. However, recent large studies have shown that dapagliflozin can also protect the kidneys and improve heart health-even in patients who do not have diabetes. There is also evidence that this drug may help improve anemia by boosting the body's ability to make red blood cells.
This study is designed to test whether dapagliflozin can provide these benefits in adults with CKD who do not have diabetes. The trial will compare dapagliflozin to a placebo (a pill with no active drug) alongside standard medical care.
Key goals of the study are to learn:
Whether dapagliflozin slows the decline of kidney function.
Whether it improves anemia by increasing hemoglobin and related blood markers.
Whether it improves heart health, including heart function and blood vessel changes.
How safe dapagliflozin is for patients with CKD who do not have diabetes.
How the study works:
About 100 adults with CKD will take part.
Participants will be randomly assigned to receive either dapagliflozin or a placebo, in addition to their usual medications.
The treatment will last for 12 months.
Participants will visit the clinic every 3 months for checkups, blood and urine tests, and heart evaluations such as echocardiography and ECG.
At the end of the study, researchers will compare kidney function, anemia markers, and heart health between the two groups.
Why this study matters: If dapagliflozin proves effective, it could become an important new option for patients with CKD who do not have diabetes. This would mean better kidney outcomes, fewer complications from anemia, and improved heart health for a large group of patients who currently have limited treatment choices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-arm, parallel assignment clinical trial. A total of 100 adults with non-diabetic chronic kidney disease (CKD) will be enrolled and randomly assigned in equal numbers to one of two groups: Intervention group: Participants will receive dapagliflozin 10 mg once daily in addition to standard CKD care. Control group: Participants will receive a placebo once daily in addition to standard CKD care. Both groups will be followed in parallel for 12 months. Outcomes related to kidney function, anemia, and cardiovascular health will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin (10Mg Tab) along with standard medical therapyParticipants receive dapagliflozin 10 mg once daily plus standard CKD care. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive placebo once daily plus standard CKD care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥18 years with a diagnosis of chronic kidney disease (CKD), non-diabetic etiology.
- Estimated glomerular filtration rate (eGFR) between 20 and 60 mL/min/1.73 m² at screening.
- Stable standard CKD care for at least 3 months prior to enrollment.
- Ability to provide written informed consent.
Key exclusion criteria (8 listed)
- Diagnosis of diabetes mellitus (type 1 or type 2).
- History of kidney transplantation or currently on dialysis.
- Acute kidney injury within the past 3 months.
- Known hypersensitivity to dapagliflozin or excipients.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Dapagliflozin (10Mg Tab) along with standard medical therapyParticipants will receive dapagliflozin 10 mg oral tablet once daily, with or without food, in addition to standard chronic kidney disease care. Treatment will continue for 12 months. | Drug | Dapagliflozin |
| PlaceboParticipants will receive a placebo oral tablet once daily, identical in appearance to dapagliflozin but containing no active drug, in addition to standard chronic kidney disease care. Treatment will continue for 12 months. | Other | Placebo |
Primary outcome
Time to first occurrence of sustained decline in kidney function or progression to end-stage kidney disease
Time frame: 12 months
Composite outcome defined as ≥50% sustained decline in estimated glomerular filtration rate (eGFR) from baseline or reaching end-stage kidney disease requiring dialysis or transplantation.
6 secondary outcomes
Change in Hemoglobin
Time frame: 12 months
Change in Serum Hepcidin
Time frame: 12 months
Change in Erythropoietin (EPO)
Time frame: 12 months
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: 12 month
Change in Coronary Artery Calcium Score
Time frame: 12 month
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: 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 15 Jan 2026.
- Background: PubMed 33065060Oshima M, Neuen BL, Jardine MJ, Bakris G, Edwards R, Levin A, Mahaffey KW, Neal B, Pollock C, Rosenthal N, Wada T, Wheeler DC, Perkovic V, Heerspink HJL. Effects of canagliflozin on anaemia in patients with type 2 diabetes and chronic kidney disease: a post-hoc analysis from the CREDENCE trial. Lancet Diabetes Endocrinol. 2020 Nov;8(11):903-914. doi: 10.1016/S2213-8587(20)30300-4.
- Background: PubMed 32044999Ghanim H, Abuaysheh S, Hejna J, Green K, Batra M, Makdissi A, Chaudhuri A, Dandona P. Dapagliflozin Suppresses Hepcidin And Increases Erythropoiesis. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgaa057. doi: 10.1210/clinem/dgaa057.
- Background: PubMed 32970396Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because of privacy concerns, regulatory restrictions, and the absence of a formal data-sharing infrastructure at the study site. De-identified aggregate results will be published, but raw participant-level data will not be made available to protect confidentiality.
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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?
A Phase 3 study testing Dapagliflozin (10Mg Tab) along with standard medical therapy in people with Chronic Kidney Disease and Anemia, run by Mansoura 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 4 inclusion and 8 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 15 Jan 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Time to first occurrence of sustained decline in kidney function or progression to end-stage kidney disease (time frame: 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 NCT07344922, which also lists 3 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 15 Jan 2026.