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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Empagliflozin (oral)
Drug10 mg
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
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Source ClinicalTrials.gov