Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients

NCT06897605 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-117'1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Erythropoiesis stimulating agent therapy dose

  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 Outcomes (1)

• Changes in hemoglobin level

  12 weeks

Study Arms (2)

Dapagliflozin + ESA group

EXPERIMENTAL

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

Drug: Dapagliflozin (DAPA); Drug: Erythropoiesis Stimulating Agent

Control group

OTHER

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

Drug: Erythropoiesis Stimulating Agent

Interventions

Dapagliflozin (DAPA) DRUG

Dapagliflizin 10 mg tablets once daily for 12 weeks

Dapagliflozin + ESA group

Erythropoiesis Stimulating Agent DRUG

Erythropoiesis stimulating agent (ESA) therapy

Control group; Dapagliflozin + ESA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia; Kidney Diseases; Bronchiolitis Obliterans Syndrome

Interventions

dapagliflozin; Hematinics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Noha O. Mansour, Ph.D.

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basma M. Sayed Ahmed, M.Sc.

CONTACT

+201207753307; basma_mohamed@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator-Associate Professor of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: April 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

EG (1)