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

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.

Timeline

Start

2022-09-01

Primary completion

2023-11-01

Completion

2023-12-01

Publications

• Background 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.
• 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.
• 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.

Drugs

Indications