Actively Recruiting
Clinical Study Evaluating the Impact of Dapagliflozin on Erythropoiesis-Stimulating Agent Responsiveness in Anemic Patients With Chronic Kidney Disease
Led by Mansoura University · Updated on 2025-04-02
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, in patients with chronic kidney disease (CKD) who also have anemia. This phase 2 clinical trial aims to explore whether dapagliflozin can improve responsiveness to erythropoiesis-stimulating agents (ESA) in treating anemia associated with CKD. Previous studies have suggested that SGLT2 inhibitors may increase hemoglobin and hematocrit levels, potentially benefiting patients with anemia due to CKD. Participants will be randomly assigned to one of two groups: one group will receive dapagliflozin 10 mg tablets once daily along with standard ESA therapy, while the other group will receive only the standard ESA therapy. The treatment period lasts 12 weeks. This trial uses a double-blind design to compare the effects of adding dapagliflozin to standard care against standard care alone. Throughout the 12-week study, participants will be monitored regularly to assess changes in the dose of ESA therapy needed and changes in hemoglobin levels. Researchers will evaluate these outcomes to determine how dapagliflozin impacts anemia management in CKD patients. Safety will also be monitored, and participation includes follow-up visits and assessments during the treatment period.
CONDITIONS
Brief Title
Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with stage III or IV chronic kidney disease
- Anemia of chronic kidney disease with hemoglobin level below 11.5 g/dL
- Currently receiving erythropoiesis-stimulating agent therapy
You will not qualify if you...
- Anemia due to causes other than chronic kidney disease, such as pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes
- Severe ketosis, diabetic coma, severe infection, perioperative complications, or severe trauma
- Acute heart failure, acute myocardial infarction, or stroke within 6 months before enrollment
- Current malignancies or history of malignancy within the past 2 years
- Diagnosed with pure red cell aplasia
- Severe gastrointestinal bleeding
- Pregnant or lactating females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive dapagliflozin once daily along with erythropoiesis-stimulating agent therapy or erythropoiesis-stimulating agent therapy alone for anemia related to chronic kidney disease.
Daily medication with periodic visits for monitoring
Trial Site Locations
Total: 1 location
1
Urology and Nephrology Center
Al Mansurah, Egypt
Actively Recruiting
Research Team
B
Basma M. Sayed Ahmed, M.Sc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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