A Phase 2 interventional study of Empagliflozin (oral) in Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0) and Albuminuria, sponsored by University of Illinois at Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by University of Illinois at Chicago · Phase 2, Interventional, and Treatment
Among 14 studies in Anemia, Sickle Cell by University of Illinois at Chicago — 3 open to participants now, 5 under way, none of them phase 3. Anemia, Sickle Cell · University of Illinois at Chicago.
Among the 14 studies in Anemia, Sickle Cell by University of Illinois at Chicago, this one is the 11th largest by planned enrollment of the 13 interventional ones, is the only one that started in 2026, is one of 3 in phase 2, and was the 12th registered.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →3 of the 14 studies in Anemia, Sickle Cell by University of Illinois at Chicago are open now, in 1 country. Each count lists the studies.
Of the 177 Anemia, Sickle Cell studies recruiting now, 64 (36%) set no upper age limit and 97 (55%) stop at 75 or younger; 127 take children under 18; 29 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2026.
Median enrollment 45 across the 13 interventional studies, 75 across the 1 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
University of Illinois at Chicago is the lead sponsor of 506 studies on the registry; 120 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Anemia, Sickle Cell by University of Illinois at Chicago, from their registry updates:
Nothing recorded among them since 2026-09-25.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including but not limited to the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Empagliflozin
Drug: Empagliflozin (oral)
10 mg
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
Effects of empagliflozin on serum biomarker: Et-1
ET-1 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 weeks
Effects of empagliflozin on serum biomarker: VCAM-1
VCAM-1 ng/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 weeks
Effects of empagliflozin on serum biomarker: sFLTI-1
sFLTI-1 ng/L 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 weeks
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Oct 2029, 42 months after the start.
Of 58 non-industry phase 2 interventional studies under Anemia, Sickle Cell, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 117. This study's planned 42 months is below that.
Counting every sponsor, half of 92 studies reached it within 46 months; a quarter within 24 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Empagliflozin
University of Illinois at Chicago →