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

NCT ID: NCT07344922

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-12-01

Brief Summary

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.

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.

Conditions

Chronic Kidney Disease; Anemia; Cardiovascular Calcification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dapagliflozin

Participants receive dapagliflozin 10 mg once daily plus standard CKD care.

Group Type: EXPERIMENTAL

Dapagliflozin (10Mg Tab) along with standard medical therapy

Intervention Type: DRUG

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

Participants receive placebo once daily plus standard CKD care

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Gamal Mosad Abu-Gharbia

Consultant Physician, Department of Nephrology and Kidney transplantation, Urology and Nephrology Center, Mansoura University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

References

Oshima M, Neuen BL, Jardine MJ, Bakris G, Edwards R, Levin A, Mahaffey KW, Neal B, Pollock C, Rosenthal N, Wada T, Wheeler DC, Perkovic V, Heerspink HJL. Effects of canagliflozin on anaemia in patients with type 2 diabetes and chronic kidney disease: a post-hoc analysis from the CREDENCE trial. Lancet Diabetes Endocrinol. 2020 Nov;8(11):903-914. doi: 10.1016/S2213-8587(20)30300-4.

Reference Type: BACKGROUND

PMID: 33065060 (View on PubMed)

Ghanim H, Abuaysheh S, Hejna J, Green K, Batra M, Makdissi A, Chaudhuri A, Dandona P. Dapagliflozin Suppresses Hepcidin And Increases Erythropoiesis. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgaa057. doi: 10.1210/clinem/dgaa057.

Reference Type: BACKGROUND

PMID: 32044999 (View on PubMed)

Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.

Reference Type: BACKGROUND

PMID: 32970396 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MS.22.04.1973

Identifier Type: -

Identifier Source: org_study_id