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Empagliflozin for Kidney Disease in Sickle Cell Anemia

This study is looking at whether empagliflozin, an FDA-approved medication, can help prevent kidney problems in people with sickle cell anemia (SCA). SCA is a blood disorder that often affects the kidneys. Empagliflozin is already used to protect kidney function in other kidney diseases. This research aims to see if it can do the same for individuals with SCA who are at high risk for advanced chronic kidney disease (CKD). You might be able to join if you are 18 to 60 years old, have a specific type of SCA (HbSS or HbSβ0-thalassemia), and have a certain level of protein in your urine (albuminuria). The study will measure specific markers in your urine, like Adenosine, Nephrin, and Kidney injury molecule-1, to see if empagliflozin is effective over 48 weeks. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured from enrollment to the end of treatment at 48 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07175051

Targeting the Pathophysiology of Sickle Cell-Related Kidney Disease Using the SGLT2 Inhibitors, Empagliflozin

Recruiting
PHASE2Ages 18–60InterventionalTreatment
University of Illinois at Chicago
~20 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Empagliflozin (oral)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of empagliflozin - urine biomarker: Adenosine
Measured over From enrollment to the end of treatment at 48 weeks
+3 more outcomes measured

Conditions

Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
Albuminuria

Explore related trials

AlbuminuriaChronic Kidney DiseaseSickle Cell Disease

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Santosh L Saraf, MD
[email protected]
312-996-5680
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
Participants with known active hepatitis A, B, or C or who are known to be human immunodeficiency virus (HIV) positive
Moderate to severe CKD (defined by an eGFR \< 30 mL/min/1.73m2, on chronic dialysis, or having received a kidney transplantation)
History of malignancy within the past 2 years prior to treatment Day 1 requiring chemotherapy and/or radiation (with the exception of local therapy for non-melanoma skin malignancy)
History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including but not limited to the following:
Any condition affecting drug absorption, such as major surgery involving the stomach (e.g. bariatric surgery) or small intestine (prior cholecystectomy is acceptable)
Participated in another clinical trial of an investigational agent (or medical device) within 30 days or 5 half-lives of agent, whichever is longer, or is currently participating in another trial of an investigational agent or medical device)
Medical, psychological, or behavioral conditions, which, in the opinion of the Investigator, may preclude safe participation, confound study interpretation, interfere with compliance, or preclude informed consent
Contraindication to MRI (certain pacemakers, electronic implants, shrapnel in the eyes, or certain intracranial aneurysm clips)

What this trial measures

  • Efficacy of empagliflozin - urine biomarker: AdenosineFrom enrollment to the end of treatment at 48 weeks

    Adenosine (umol/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.

  • Efficacy of empagliflozin - urine biomarker: NephrinFrom enrollment to the end of treatment at 48 weeks

    Nephrin (ng/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.

  • Efficacy of empagliflozin - urine biomarker: Kidney injury molecule-1From enrollment to the end of treatment at 48 weeks

    Kidney injury molecule-1 (ng/g creatinine) average values from Screening \& Visit 1 compared to average values from Visit 5 \& 6.

  • Efficacy of empagliflozin R2* Cortical Oxygenation on kidney fMRIFrom enrollment to the end of treatment at 48 weeks

    fMRI-derived R2\* average values from Visit 1 compared to the values from Visit 6.