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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
10 mg
University of Illinois Chicago, Sickle Cell Center
Chicago, Illinois, United States
Efficacy of empagliflozin - urine biomarker: Adenosine
Adenosine (umol/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Time frame: From enrollment to the end of treatment at 48 weeks
Efficacy of empagliflozin - urine biomarker: Nephrin
Nephrin (ng/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Time frame: From enrollment to the end of treatment at 48 weeks
Efficacy of empagliflozin - urine biomarker: Kidney injury molecule-1
Kidney injury molecule-1 (ng/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Time frame: From enrollment to the end of treatment at 48 weeks
Efficacy of empagliflozin R2* Cortical Oxygenation on kidney fMRI
fMRI-derived R2\* average values from Visit 1 compared to the values from Visit 6.
Time frame: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on UACR
Change in UACR (mg/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6
Time frame: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on 24-hour urine protein
24-hour urine protein (g/24 hours) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Time frame: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on measures of eGFR
eGFR calculated by race-free serum creatinine and cystatin C-based equations (mL/min/1.73m2), average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6
Time frame: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on serum biomarker: suPAR
suPAR pg/mL average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Time frame: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on serum biomarker: Et-1
ET-1 pg/mL average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Time frame: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on serum biomarker: VCAM-1
VCAM-1 ng/mL average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Time frame: From enrollment to the end of treatment at 48 weeks
Effects of empagliflozin on serum biomarker: sFLTI-1
sFLTI-1 ng/L average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.
Time frame: From enrollment to the end of treatment at 48 weeks
Anand Srivastave, MD
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