Targeting the Pathophysiology of Sickle Cell-Related Kidney Disease Using the SGLT2 Inhibitors, Empagliflozin
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Illinois at Chicago
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Empagliflozin (oral)
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov