Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients

March 27, 2025 updated by: Noha Mansour, Mansoura University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Recruiting
        • Urology and nephrology center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapagliflozin + ESA group
patients will receive dapagliflozin 10 mg tablet once daily in addition to standard care therapy of erythropoiesis-stimulating agents (ESA)
Drug: Dapagliflozin (DAPA)
Dapagliflizin 10 mg tablets once daily for 12 weeks
Drug: Erythropoiesis Stimulating Agent
Erythropoiesis stimulating agent (ESA) therapy
Other: Control group
patients will receive standard care therapy of erythropoiesis-stimulating agents (ESA)
Drug: Erythropoiesis Stimulating Agent
Erythropoiesis stimulating agent (ESA) therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in hemoglobin level
Time Frame: 12 weeks
Difference between two groups in hemoglobin level in g/dL at the end of the study.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Noha O. Mansour, Ph.D., Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-117'1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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