Using Dapagliflozin to Treat Anemia in Patients with Chronic Kidney Disease
Clinical Study Evaluating the Impact of Dapagliflozin on Erythropoiesis-Stimulating Agent Responsiveness in Anemic Patients With Chronic Kidney Disease
This study is testing if the diabetes medication dapagliflozin can help raise hemoglobin levels in adults with chronic kidney disease and anemia who are already on other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah) |
| Trial ID | NCT06897605 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of dapagliflozin, a medication typically used for type 2 diabetes, on anemia in adults with chronic kidney disease (CKD) stages III and IV. The study aims to determine if dapagliflozin can elevate hemoglobin levels in patients who are already receiving erythropoiesis-stimulating agents. By analyzing the outcomes of these patients, the trial seeks to explore the potential benefits of dapagliflozin beyond its primary use. The approach involves monitoring hemoglobin and hematocrit levels in participants over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with CKD stage III or IV and a hemoglobin level below 11.5 g/dL who are receiving erythropoiesis-stimulating agents.
Not a fit: Patients with anemia due to causes other than chronic kidney disease or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve hemoglobin levels and overall health outcomes for patients with anemia related to chronic kidney disease.
How similar studies have performed: Previous studies have indicated that SGLT2 inhibitors like dapagliflozin may improve hemoglobin levels in CKD patients, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Adults aged ≥ 18 years with CKD stage III or IV. 2. Patients with anemia of CKD and a hemoglobin level \< 11.5 g/dL 3. Patients are receiving erythropoiesis-stimulating agent therapy. Exclusion criteria 1. Anemia due to causes other than chronic kidney disease, such as pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes. 2. Patients with severe ketosis, diabetic coma, severe infection, perioperative complications, or severe trauma. 3. Patients with acute heart failure, acute myocardial infarction, or stroke occurring within 6 months before enrollment in the trial. 4. Patients with current malignancies or a history of malignancy within the past 2 years. 5. Diagnosed with pure red cell aplasia. 6. Patients with severe gastrointestinal bleeding. 7. Pregnant or lactating females.
Where this trial is running
Al Mansurah
- Urology and Nephrology Center — Al Mansurah, Egypt (Recruiting)
Study contacts
- Principal investigator: Noha O. Mansour, Ph.D. — Mansoura University
- Study coordinator: Basma M. Sayed Ahmed, M.Sc.
- Email: basma_mohamed@mans.edu.eg
- Phone: +201207753307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.