SGLT2 Inhibitors in Non-Diabetic CKD: Effects on Vascular Calcification and Anemia

January 8, 2026 updated by: Mostafa Gamal Mosad Abu-Gharbia, Mansoura University

Impact of Sodium-Glucose Co-transporter 2 Inhibitors on Cardiovascular System and Anemia in Non-diabetic Chronic Kidney Disease Patients. A Randomized-Controlled Clinical Trial

The goal of this clinical trial is to learn if the drug dapagliflozin (an SGLT2 inhibitor) can help protect the kidneys, improve anemia, and support heart health in adults with chronic kidney disease (CKD) who do not have diabetes. The main questions it aims to answer are:

Does dapagliflozin slow the worsening of kidney function compared to standard care?

Does dapagliflozin improve anemia by increasing hemoglobin and related blood markers?

Does dapagliflozin improve heart function and reduce cardiovascular problems in CKD patients?

Researchers will compare dapagliflozin to a placebo (a look-alike pill with no active drug) to see if dapagliflozin works better than standard treatment alone.

Participants will:

Take dapagliflozin or a placebo once daily for 12 months, along with their usual CKD medications.

Visit the clinic every 3 months for checkups, blood tests, urine tests, and heart evaluations.

Have measurements of kidney function, anemia markers, and heart health taken at baseline and during follow-up visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic kidney disease (CKD) is a serious health problem that affects millions of people worldwide. It often leads to worsening kidney function, anemia (low blood count), and heart problems. While diabetes is a common cause of CKD, many patients develop kidney disease without having diabetes. These patients still face high risks of anemia and cardiovascular complications, but treatment options remain limited.

Dapagliflozin, a medicine from the sodium-glucose co-transporter 2 (SGLT2) inhibitor family, was originally developed to lower blood sugar in people with diabetes. However, recent large studies have shown that dapagliflozin can also protect the kidneys and improve heart health-even in patients who do not have diabetes. There is also evidence that this drug may help improve anemia by boosting the body's ability to make red blood cells.

This study is designed to test whether dapagliflozin can provide these benefits in adults with CKD who do not have diabetes. The trial will compare dapagliflozin to a placebo (a pill with no active drug) alongside standard medical care.

Key goals of the study are to learn:

Whether dapagliflozin slows the decline of kidney function.

Whether it improves anemia by increasing hemoglobin and related blood markers.

Whether it improves heart health, including heart function and blood vessel changes.

How safe dapagliflozin is for patients with CKD who do not have diabetes.

How the study works:

About 100 adults with CKD will take part.

Participants will be randomly assigned to receive either dapagliflozin or a placebo, in addition to their usual medications.

The treatment will last for 12 months.

Participants will visit the clinic every 3 months for checkups, blood and urine tests, and heart evaluations such as echocardiography and ECG.

At the end of the study, researchers will compare kidney function, anemia markers, and heart health between the two groups.

Why this study matters: If dapagliflozin proves effective, it could become an important new option for patients with CKD who do not have diabetes. This would mean better kidney outcomes, fewer complications from anemia, and improved heart health for a large group of patients who currently have limited treatment choices.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt, 35511
        • Urology and Nephrology center, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged ≥18 years with a diagnosis of chronic kidney disease (CKD), non-diabetic etiology.
  • Estimated glomerular filtration rate (eGFR) between 20 and 60 mL/min/1.73 m² at screening.
  • Stable standard CKD care for at least 3 months prior to enrollment.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Diagnosis of diabetes mellitus (type 1 or type 2).
  • History of kidney transplantation or currently on dialysis.
  • Acute kidney injury within the past 3 months.
  • Known hypersensitivity to dapagliflozin or excipients.
  • Pregnant or breastfeeding women.
  • Participation in another interventional clinical trial within the past 30 days.
  • Severe uncontrolled cardiovascular disease (e.g., recent myocardial infarction, unstable angina, decompensated heart failure).
  • Any condition judged by the investigator to interfere with study participation or interpretation of results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapagliflozin
Participants receive dapagliflozin 10 mg once daily plus standard CKD care.
Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy
Participants will receive dapagliflozin 10 mg oral tablet once daily, with or without food, in addition to standard chronic kidney disease care. Treatment will continue for 12 months.
Placebo Comparator: Placebo
Participants receive placebo once daily plus standard CKD care
Other: Placebo
Participants will receive a placebo oral tablet once daily, identical in appearance to dapagliflozin but containing no active drug, in addition to standard chronic kidney disease care. Treatment will continue for 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first occurrence of sustained decline in kidney function or progression to end-stage kidney disease
Time Frame: 12 months
Composite outcome defined as ≥50% sustained decline in estimated glomerular filtration rate (eGFR) from baseline or reaching end-stage kidney disease requiring dialysis or transplantation.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin
Time Frame: 12 months
Change from baseline in hemoglobin levels (g/dL).
12 months
Change in Serum Hepcidin
Time Frame: 12 months
Change from baseline in serum hepcidin levels (ng/mL).
12 months
Change in Erythropoietin (EPO)
Time Frame: 12 months
Change from baseline in erythropoietin levels (mIU/mL).
12 months
Change in Left Ventricular Ejection Fraction (LVEF)
Time Frame: 12 month
Change from baseline in LVEF assessed by echocardiography (percentage).
12 month
Change in Coronary Artery Calcium Score
Time Frame: 12 month
Change from baseline in coronary artery calcium score (Agatston score).
12 month
Incidence of Major Adverse Cardiovascular Events (MACE)
Time Frame: 12 months
Number of participants with at least one Major Adverse Cardiovascular Event, defined as a composite of: myocardial infarction, stroke, or hospitalization for heart failure (Participants).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

December 14, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS.22.04.1973

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because of privacy concerns, regulatory restrictions, and the absence of a formal data-sharing infrastructure at the study site. De-identified aggregate results will be published, but raw participant-level data will not be made available to protect confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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