Targeting the Pathophysiology of Sickle Cell-Related Kidney Disease Using the SGLT2 Inhibitors, Empagliflozin
Eligible age
18–60 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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).
Sponsor: University of Illinois at Chicago
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ Concurrent diagnosis of diabetes mellitus
- ✕ Female who is breast feeding, pregnant, or unwilling to use birth control as described in the protocol
- ✕ Prior hypersensitivity or intolerance to a sodium-glucose cotransporter-2 inhibitor (SGLT2i)
- ✕ Active or open leg ankle ulcer
- ✕ Chronic urinary tract infection
- ✕ Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days prior to signing consent
- ✕ Hepatic dysfunction characterized by alanine aminotransferase (ALT) \>5× ULN
- ✕ Participants with acute bacterial infection requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed
Where it's recruiting
Chicago
Source: ClinicalTrials.gov · NCT07175051 · last updated 2026-05-19