Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06897605

Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Kidney Disease(CKD) Anemia Anemia, Kidney Disease, Chronic Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Urology and Nephrology Center

Al Mansurah, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Dapagliflozin (DAPA)

Drug

Dapagliflizin 10 mg tablets once daily for 12 weeks

Erythropoiesis Stimulating Agent

Drug

Erythropoiesis stimulating agent (ESA) therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in hemoglobin level

    Time frame: 12 weeks

    Difference between two groups in hemoglobin level in g/dL at the end of the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Basma M. Sayed Ahmed, M.Sc.

CONTACT

[email protected]

+201207753307

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Clinical Study Evaluating the Impact of Dapagliflozin on Erythropoiesis-Stimulating Agent Responsiveness in Anemic Patients With Chronic Kidney Disease

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.