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Recruiting NCT06897605

Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients

Phase II Interventional Chronic Kidney Disease(CKD) Anemia, Kidney Disease, Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dapagliflozin (DAPA), Erythropoiesis Stimulating Agent.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease(CKD), Anemia, Kidney Disease, Chronic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Dapagliflozin (DAPA)
    Dapagliflizin 10 mg tablets once daily for 12 weeks
  • Drug Erythropoiesis Stimulating Agent
    Erythropoiesis stimulating agent (ESA) therapy

Primary outcome measures

  • Change in Erythropoiesis stimulating agent therapy dose [Time frame: 12 weeks]
Secondary outcome measures (1)
  • Changes in hemoglobin level [Time frame: 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Urology and Nephrology Center — Al Mansurah

Identifiers

NCT: NCT06897605 · 2024-117'1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗