Sickle cell kidney hope: common diabetes drug tested to save kidneys
NCT ID NCT07175051
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether empagliflozin, a drug already approved for kidney disease in diabetes, can slow kidney damage in people with sickle cell anemia. About 20 adults with sickle cell disease and early signs of kidney trouble will take the drug for 6 months. Researchers will measure changes in urine and kidney scans to see if the drug helps protect kidney function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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: 1. Unstable angina pectoris or myocardial infarction or elective coronary intervention 2. Uncontrolled clinically significant arrhythmias * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Illinois Chicago, Sickle Cell Center
RECRUITINGChicago, Illinois, 60302, United States
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