Chronic Kidney Disease(CKD)Phase 2NCT06897605
Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients
A Phase 2 study testing Dapagliflozin (DAPA) and Erythropoiesis Stimulating Agent in people with Chronic Kidney Disease(CKD) and Anemia, Kidney Disease, Chronic, run by Mansoura University at 1 site in Egypt.
Trial summary
Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, primarily used in the management of type 2 diabetes mellitus. Emerging research suggests that SGLT2 inhibitors may offer additional benefits, including reducing the risk of cardiovascular events and renal complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease(CKD), Anemia, Kidney Disease, Chronic
- What is being tested?
- Dapagliflozin (DAPA) and Erythropoiesis Stimulating Agent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to Oct 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 CKD stage III or IV.
- Patients with anemia of CKD and a hemoglobin level < 11.5 g/dL
- Patients are receiving erythropoiesis-stimulating agent therapy.
Who cannot join
- Anemia due to causes other than chronic kidney disease, such as pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes.
- Patients with severe ketosis, diabetic coma, severe infection, perioperative complications, or severe trauma.
- Patients with acute heart failure, acute myocardial infarction, or stroke occurring within 6 months before enrollment in the trial.
- Patients with current malignancies or a history of malignancy within the past 2 years.
- Diagnosed with pure red cell aplasia.
- Patients with severe gastrointestinal bleeding.
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study Evaluating the Impact of Dapagliflozin on Erythropoiesis-Stimulating Agent Responsiveness in Anemic Patients With Chronic Kidney Disease
Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, primarily used in the management of type 2 diabetes mellitus. Emerging research suggests that SGLT2 inhibitors may offer additional benefits, including reducing the risk of cardiovascular events and renal complications. Post hoc analyses of previous clinical trials have shown that patients treated with SGLT2 inhibitors exhibited higher levels of hemoglobin and hematocrit compared to those in the control group. These findings suggest that dapagliflozin's ability to elevate hemoglobin levels could potentially be utilized for the treatment of anemia in patients with chronic kidney disease.
- Being tested
- Dapagliflozin (DAPA), Erythropoiesis Stimulating Agent
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia, Kidney Diseases, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (DAPA)Drug
Dapagliflizin 10 mg tablets once daily for 12 weeks
Erythropoiesis Stimulating AgentDrug
Erythropoiesis stimulating agent (ESA) therapy
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin + ESA group | Experimental | patients will receive dapagliflozin 10 mg tablet once daily in addition to standard care therapy of erythropoiesis-stimulating agents (ESA) Receives: Drug: Dapagliflozin (DAPA); Drug: Erythropoiesis Stimulating Agent |
| Control group | Other | patients will receive standard care therapy of erythropoiesis-stimulating agents (ESA) Receives: Drug: Erythropoiesis Stimulating Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Erythropoiesis stimulating agent therapy dose
Difference between two groups in comulative dose of erythropoiesis stimulating agent therapy (E.S.A) in international unit (I.U) at the end of the study.
Measured: 12 weeks
Secondary outcomes (1)
Changes in hemoglobin level
Difference between two groups in hemoglobin level in g/dL at the end of the study.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease(CKD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
- Investigators
- Noha O. Mansour, Ph.D., Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897605
- Sponsor's protocol ID
- 2024-117'1
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Impact of Dapagliflozin on Erythropoiesis-Stimulating Agent Responsiveness in Anemic Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06897605
- Acronym / sponsor ID
- 2024-117'1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 27 Mar 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.
Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, primarily used in the management of type 2 diabetes mellitus. Emerging research suggests that SGLT2 inhibitors may offer additional benefits, including reducing the risk of cardiovascular events and renal complications. Post hoc analyses of previous clinical trials have shown that patients treated with SGLT2 inhibitors exhibited higher levels of hemoglobin and hematocrit compared to those in the control group. These findings suggest that dapagliflozin's ability to elevate hemoglobin levels could potentially be utilized for the treatment of anemia in patients with chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin + ESA group | Experimental | Drug: Dapagliflozin (DAPA), Drug: Erythropoiesis Stimulating Agentpatients will receive dapagliflozin 10 mg tablet once daily in addition to standard care therapy of erythropoiesis-stimulating agents (ESA) |
| Control group | Other | Drug: Erythropoiesis Stimulating Agentpatients will receive standard care therapy of erythropoiesis-stimulating agents (ESA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥ 18 years with CKD stage III or IV.
- Patients with anemia of CKD and a hemoglobin level < 11.5 g/dL
- Patients are receiving erythropoiesis-stimulating agent therapy.
Key exclusion criteria (7 listed)
- Anemia due to causes other than chronic kidney disease, such as pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes.
- Patients with severe ketosis, diabetic coma, severe infection, perioperative complications, or severe trauma.
- Patients with acute heart failure, acute myocardial infarction, or stroke occurring within 6 months before enrollment in the trial.
- Patients with current malignancies or a history of malignancy within the past 2 years.
- Diagnosed with pure red cell aplasia.
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 (DAPA)Dapagliflizin 10 mg tablets once daily for 12 weeks | Drug | Dapagliflozin + ESA group |
| Erythropoiesis Stimulating AgentErythropoiesis stimulating agent (ESA) therapy | Drug | Control group, Dapagliflozin + ESA group |
Primary outcome
Change in Erythropoiesis stimulating agent therapy dose
Time frame: 12 weeks
Difference between two groups in comulative dose of erythropoiesis stimulating agent therapy (E.S.A) in international unit (I.U) at the end of the study.
1 secondary outcome
Changes in hemoglobin level
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
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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.
Noha O. Mansour, Ph.D. principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin (DAPA) and Erythropoiesis Stimulating Agent in people with Chronic Kidney Disease(CKD) and Anemia, Kidney Disease, Chronic, 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Apr 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Basma M. Sayed Ahmed, M.Sc. (+201207753307, basma_mohamed@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Erythropoiesis stimulating agent therapy dose (time frame: 12 weeks). 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 2 Apr 2025.