Anemia-Related Outcomes in Patients With CKD Treated With Dapagliflozin

Anemia-Related Outcomes in Patients with CKD Treated with Dapagliflozin

This study aims to identify factors that predict anemia improvement in chronic kidney disease (CKD) patients using Dapagliflozin, an SGLT2 inhibitor.

Key questions:

• What factors influence how well Dapagliflozin improves anemia in CKD patients?
• Are there specific characteristics that predict better responses to Dapagliflozin treatment?

The investigators will review medical records of CKD patients who started taking Dapagliflozin. The investigators will compare those with low hemoglobin levels (anemia) to those without anemia.

The investigators will analyze:

Changes in hemoglobin levels Other factors related to anemia (e.g., iron levels, TIBC, ferritin) Patient characteristics (e.g., age, sex, CKD stage)

This study will help us understand which CKD patients are most likely to benefit from Dapagliflozin for anemia.

Study Overview

• Status: Active, not recruiting
• Conditions: Anemia; CKD
• Intervention / Treatment: Drug: Dapagliflozin (DAPA)

Detailed Description

Study Title: Anemia-Related Outcomes in Patients with CKD Treated with Dapagliflozin

Purpose:

This prospective observational study aims to investigate factors associated with anemia improvement in CKD patients treated with Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor. The study will analyze data from medical records to identify predictors of favorable anemia outcomes in this population.

Study Design:

A prospective cohort study will be conducted using medical records from the Kidney and Urology Center in Alexandria, Egypt. Patients with CKD who initiated Dapagliflozin therapy will be included, and their clinical data will be analyzed to assess the impact of Dapagliflozin on anemia.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Egypt
  • Damanhour, Egypt, 22514
    • Damanhour University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The target population for this study consists of adult patients with diabetes chronic kidney disease (CKD) who have initiated treatment with Dapagliflozin, an SGLT2 inhibitor in comparison with patients with diabetes and CKD on antidiabetic drugs other than dapagliflozin

Description

Inclusion Criteria:

• Adults (age > 18 years) diagnosed with CKD based on estimated glomerular filtration rate (eGFR) criteria established by Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.

  • Initiated treatment with Dapagliflozin for a minimum follow-up duration of 12 months.
  • Documented hemoglobin levels before and after Dapagliflozin initiation.
  • For patients receiving antidiabetic drug classes other that Dapagliflozin, they should be on stable doses for at least 4 weeks prior to trial enrollment.
  • For patients treated with ACE inhibitors or ARBs, they should be on stable doses for at least 4 weeks prior to trial enrollment.

Exclusion Criteria:

• • Active malignancy or other life-limiting conditions.

  • Pregnancy.
  • Specific Kidney Diseases: Autosomal dominant or autosomal recessive polycystic kidney disease, Nephrotic syndrome, Lupus nephritis, and ANCA-associated vasculitis.
  • Receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy for primary or secondary renal disease within 6 months before enrollment.
  • Receiving therapy with an SGLT2 inhibitors and/or erythropoiesis stimulating agent (ESA) within 8 weeks before enrollment or previous intolerance of an SGLT2 inhibitors.
  • Type 1 diabetes mellitus.
  • Patients who had received red blood cell transfusions within 6 months before enrollment.
  • Patients who had significant active blood loss due to surgical procedures or medical conditions within 12 weeks before, and/or during enrollment.
  • Iron deficiency at baseline defined as a ferritin level <100 ng/mL or a TSAT <20% and a ferritin level 100 to 299 ng/mL.
  • Cause of anemia other than CKD.
  • Patients with Serum iPTH >600 pg/mL at Screening.
  • Receiving any investigational drug within 4 weeks prior to enrollment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with diabetes and CKD receiving Dapagliflozin with and without anemia; Anemia is defined as a baseline of Hb <13.0 g/dl in males and <12.0 g/dl in females	Drug: Dapagliflozin (DAPA); Dapagliflozin 10 mg
Patients with diabetes and CKD receiving antidiabetic drugs other than dapagliflozin; Stable doses of antidiabetic agents (other than dapagliflozin) for ≥4 weeks prior to enrollment.	Drug: Dapagliflozin (DAPA); Dapagliflozin 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin Changes	12 months

Collaborators and Investigators

• Sponsor: Damanhour University
• Investigators: Study Director: Amira Kassem, BPharm, MS, PhD, Faculty of Pharmacy, Damanhour University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Dapagliflozin; Anemia; CKD; SGLT2i
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Dapagliflozin
• Other Study ID Numbers: Dapa-Anemia-DM-CKD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes