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New treatment option for Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
Official title Targeting the Pathophysiology of Sickle Cell-Related Kidney Disease Using the SGLT2 Inhibitors, Empagliflozin
ClinicalTrials.gov ID: NCT07175051
What this study is testing
What is Empagliflozin (oral)?
Empagliflozin (oral) is an investigational medicine, being studied as a potential treatment for sickle cell anemia (hbss, or hbsβ-thalassemia0).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Sickle cell anemia (SCA) is an inherited red blood disorder. The kidneys are among the most commonly affected organ systems in SCA.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- For participants on crizanlizumab or chronic red blood cell transfusions, the therapy must have started at least 3 months prior to consent
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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:
- Unstable angina pectoris or myocardial infarction or elective coronary intervention
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.