Anemia-Related Outcomes in Patients With CKD Treated With Dapagliflozin

NCT06813222 | Active Not Recruiting FDA Drug

• 1 other identifier: Dapa-Anemia-DM-CKD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia; CKD

Keywords

Anemia; CKD; SGLT2i; Dapagliflozin

Outcome Measures

Primary Outcomes (1)

• Hemoglobin Changes

  12 months

Study Arms (2)

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)

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)

Interventions

Dapagliflozin (DAPA) DRUG

Dapagliflozin 10 mg

Patients with diabetes and CKD receiving Dapagliflozin with and without anemia; Patients with diabetes and CKD receiving antidiabetic drugs other than dapagliflozin

Eligibility Criteria

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

You may qualify if:

• Adults (age \&gt; 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.

You may not qualify if:

• 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 \&lt;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 \&gt;600 pg/mL at Screening.
• Receiving any investigational drug within 4 weeks prior to enrollment.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Damanhour University

Damanhur, 22514, Egypt

Location

MeSH Terms

Conditions

Anemia

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Amira Kassem, BPharm, MS, PhD

  Faculty of Pharmacy, Damanhour University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: February 6, 2025
• Study Start: April 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

EG (1)