Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease(CKD) Anemia, Kidney Disease, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Dapagliflozin + ESA group

patients will receive dapagliflozin 10 mg tablet once daily in addition to standard care therapy of erythropoiesis-stimulating agents (ESA)

Group Type EXPERIMENTAL

Dapagliflozin (DAPA)

Intervention Type DRUG

Dapagliflizin 10 mg tablets once daily for 12 weeks

Erythropoiesis Stimulating Agent

Intervention Type DRUG

Erythropoiesis stimulating agent (ESA) therapy

Control group

patients will receive standard care therapy of erythropoiesis-stimulating agents (ESA)

Group Type OTHER

Erythropoiesis Stimulating Agent

Intervention Type DRUG

Erythropoiesis stimulating agent (ESA) therapy

Interventions

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Dapagliflozin (DAPA)

Dapagliflizin 10 mg tablets once daily for 12 weeks

Intervention Type DRUG

Erythropoiesis Stimulating Agent

Erythropoiesis stimulating agent (ESA) therapy

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No