Phase 2 Sickle Cell Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with a specific type of sickle cell disease (called HbSS or HbSβ0-thalassemia), confirmed by genetic testing
• Your urine tests show a certain level of kidney protein leakage (called albuminuria), within a specific range measured at your screening appointment
• Your hemoglobin (red blood cell) level is at least 5.5 g/dL at screening
• If you take a medication called Endari, your dose has been stable for at least one month before joining and is not expected to change during the study
• If you take crizanlizumab or receive regular blood transfusions, you must have been on that treatment for at least 3 months before joining
• If you take certain blood pressure medications (ACE inhibitors or ARBs), your dose has been stable for at least 3 months before joining and is not expected to change during the study
• You have a history of regularly attending clinic appointments and following your outpatient care plan
• If you are a woman who could become pregnant, you agree to use highly effective birth control from the start of the study until 30 days after your last dose
• You have given your written informed consent to participate

Who may not be able to join:

• You have been diagnosed with diabetes
• You are currently pregnant, breastfeeding, or unwilling to use birth control as required by the study
• You have previously had a bad reaction or intolerance to a type of medication called an SGLT2 inhibitor
• You currently have an open or active leg or ankle ulcer
• You have a long-term (chronic) urinary tract infection
• You were hospitalised for a sickle cell crisis or similar painful episode within the 14 days before signing consent
• Your liver is not functioning well, based on a specific blood test result being more than 5 times the normal upper limit
• You currently have a bacterial infection that requires antibiotics (you may be able to join after finishing the course of antibiotics)
• You have active hepatitis A, B, or C, or are HIV positive
• You have moderate to severe kidney disease (confirm with trial site), are on dialysis, or have received a kidney transplant
• You have been treated for cancer with chemotherapy or radiation in the past 2 years (except for certain minor skin cancer treatments)
• You have had unstable or worsening heart or lung disease in the past 6 months, including heart attacks, uncontrolled irregular heartbeat, or related procedures
• You have had major surgery on your stomach or small intestine that could affect how your body absorbs medication (having had your gallbladder removed is acceptable)
• You have taken part in another clinical trial of an experimental treatment within the past 30 days (or longer, depending on the medication), or are currently in another trial
• You have a medical, mental health, or behavioural condition that the trial doctor believes could make participation unsafe or affect the study results (confirm with trial site)
• You are unable to have an MRI scan — for example, due to certain pacemakers, electronic implants, metal fragments in the eyes, or certain types of brain aneurysm clips

Important: Always verify eligibility with the trial site directly before applying.