Targeting the Pathophysiology of Sickle Cell-Related Kidney Disease Using the SGLT2 Inhibitors, Empagliflozin
Sickle cell anemia (SCA) is an inherited red blood disorder. The kidneys are among the most commonly affected organ systems in SCA. The Food and Drug Administration (FDA) has approved empagliflozin as a treatment to reduce the decline of kidney function in those with kidney disease. The proposed research study aims to determine whether empagliflozin can prevent the progression of kidney dysfunction in patients with sickle cell anemia (SCA) who are at high risk of developing advanced chronic kidney disease (CKD).
• Documentation of SCA genotype (HbSS or HbSβ0-thalassemia)
• Albuminuria defined by a UACR of 100 - 2,000 mg/g creatinine at the screening
• Hemoglobin (Hb) ≥ 5.5 g/dL during screening
• For participants taking Endari, the dose of Endari must be stable for at least one month prior to signing the ICF and with no anticipated need for dose adjustments during the study
• For participants on crizanlizumab or chronic red blood cell transfusions, the therapy must have started at least 3 months prior to consent
• For participants taking an angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB), the dose must be stable for at least 3 months prior to signing the ICF and with no anticipated need for dose adjustments during the study, in the opinion of the Investigator
• Participants must demonstrate regular compliance with clinic visits and outpatient management
• Participants, if female and of childbearing potential, will use highly effective methods of contraception from study start to 30 days after the last dose of the study drug
• Participant has provided documented informed consent or assent