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

NCT07344922 | Completed Phase 3

• 1 other identifier: MS.22.04.1973
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Chronic Kidney Disease; Cardiovascular Calcification

Keywords

dapagliflozin; Anemia; vascular calcification

Outcome Measures

Primary Outcomes (1)

• Time to first occurrence of sustained decline in kidney function or progression to end-stage kidney disease

  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 Outcomes (6)

• Change in Hemoglobin

  12 months

• Change in Serum Hepcidin

  12 months

• Change in Erythropoietin (EPO)

  12 months

• Change in Left Ventricular Ejection Fraction (LVEF)

  12 month

• Change in Coronary Artery Calcium Score

  12 month

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

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

Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy

Placebo

PLACEBO COMPARATOR

Participants receive placebo once daily plus standard CKD care

Other: Placebo

Interventions

Dapagliflozin (10Mg Tab) along with standard medical therapy 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.

Dapagliflozin

Placebo 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.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (3)

• 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.

  PMID: 33065060 BACKGROUND

• 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.

  PMID: 32044999 BACKGROUND

• 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.

  PMID: 32970396 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia; Vascular Calcification

Interventions

dapagliflozin; Tablets

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is a randomized, double-blind, placebo-controlled trial. Participants, care providers, investigators, and outcomes assessors were all masked to treatment assignment. Study medications (dapagliflozin or placebo) are identical in appearance, packaging, and administration schedule to maintain blinding throughout the trial. Randomization codes were securely held and only revealed after study completion or in case of medical necessity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician, Department of Nephrology and Kidney transplantation, Urology and Nephrology Center, Mansoura University

Model Details: This is a randomized, double-arm, parallel assignment clinical trial. A total of 100 adults with non-diabetic chronic kidney disease (CKD) will be enrolled and randomly assigned in equal numbers to one of two groups: Intervention group: Participants will receive dapagliflozin 10 mg once daily in addition to standard CKD care. Control group: Participants will receive a placebo once daily in addition to standard CKD care. Both groups will be followed in parallel for 12 months. Outcomes related to kidney function, anemia, and cardiovascular health will be compared between the two groups.

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: January 15, 2026
• Study Start: September 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)