Studying Empagliflozin to Prevent Kidney Disease Progression in Adults with Sickle Cell Anemia and Albuminuria
Led by University of Illinois at Chicago · Updated on 2026-05-19
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Sickle cell anemia SCA is a genetic red blood cell disorder that often affects the kidneys. This research aims to see if empagliflozin, a drug approved by the FDA to slow kidney function decline, can prevent worsening kidney problems in people with SCA at high risk for advanced chronic kidney disease. The study is a Phase 2 clinical trial sponsored by the University of Illinois at Chicago.
Participants will receive empagliflozin orally at a dose of 10 mg. The treatment period lasts 48 weeks during which urine and blood biomarkers, as well as kidney imaging, will be used to evaluate the drugs effects. Key urine markers include adenosine, nephrin, and kidney injury molecule-1, while kidney cortical oxygenation will be assessed by fMRI. Additional measures include urine protein levels, estimated glomerular filtration rate, and various serum biomarkers.
During the study, participants will have regular clinic visits for monitoring compliance and safety. They will undergo urine and blood tests, kidney imaging scans, and assessments of kidney function and injury markers throughout the 48-week treatment period. The study tracks changes from enrollment to the end of treatment to determine how empagliflozin affects kidney health in SCA patients.
CONDITIONS
Brief Title
Targeting the Pathophysiology of Sickle Cell-Related Kidney Disease Using the SGLT2 Inhibitors, Empagliflozin
Research Team
S
Santosh L Saraf, MD
A
Anand Srivastave, MD
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Empagliflozin (SGLT2 inhibitor)
ACEi or ARB standard care
What it is
An oral SGLT2 inhibitor (empagliflozin) given at 10 mg daily, under investigation for reducing markers of kidney injury in adults with sickle cell anemia and albuminuria.
Angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) are oral medications used as standard therapy to reduce albuminuria and slow kidney disease progression in people with sickle cell disease.
Role in the trial
All eligible participants receive empagliflozin to evaluate effects on kidney biomarkers and albuminuria.
ACEi/ARB is typically prescribed as routine standard care for albuminuria in sickle cell disease based on clinical practice.
Primary use
To determine if empagliflozin can reduce albuminuria and improve kidney injury-related biomarkers in adults with sickle cell anemia.
To decrease albuminuria and preserve kidney function in patients with sickle cell disease who show signs of nephropathy.
How it is given or performed
Taken once daily as an oral pill (10 mg) for up to 48 weeks.
ACEi or ARB is taken orally, once or twice daily, with dosing tailored to individual patient needs and blood pressure.
Evidence status
No efficacy data yet available in sickle cell nephropathy. Empagliflozin is being studied in this population for effects on albuminuria and renal biomarkers; results are awaited.
Evidence from randomized and multicenter trials suggests ACEi and ARBs can reduce albuminuria and stabilize kidney function in adults with sickle cell disease.
Important limitations
This is a single-arm trial, so its results may be limited by the lack of direct, randomized comparison to current-care options. Any effect of empagliflozin in sickle cell nephropathy remains uncertain until results are reported.
While ACEi/ARB are standard of care and supported by evidence in SCD-related proteinuria, improvements in clinical outcomes such as end-stage kidney disease or mortality specifically in SCD remain less well proven, and blood pressure and tolerance must be monitored.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
Documentation of sickle cell anemia genotype (HbSS or HbSβ0-thalassemia)
Albuminuria defined by a urine albumin-to-creatinine ratio (UACR) of 100 to 2,000 mg/g at screening
Hemoglobin level of at least 5.5 g/dL during screening
Stable dose of Endari for at least one month prior to consent if taking this medication
Crizanlizumab or chronic red blood cell transfusions started at least 3 months before consent if receiving these therapies
Stable dose of ACE inhibitor or angiotensin II receptor blocker for at least 3 months prior to consent if taking these medications
Regular compliance with clinic visits and outpatient care
Use of highly effective contraception from study start to 30 days after last dose for females of childbearing potential
Documented informed consent or assent provided
You will not qualify if you...
Diagnosis of diabetes mellitus
Female who is pregnant, breastfeeding, or unwilling to use birth control as required
Prior hypersensitivity or intolerance to sodium-glucose cotransporter-2 inhibitors (SGLT2i)
Active or open leg or ankle ulcers
Chronic urinary tract infection
Hospitalization for sickle cell crisis or vaso-occlusive event within 14 days before consent
Liver dysfunction with ALT levels over 5 times the upper limit of normal
Acute bacterial infection requiring antibiotics at screening
Known active hepatitis A, B, or C infection or HIV positive status
Moderate to severe chronic kidney disease with eGFR below 30 mL/min/1.73m2, dialysis, or kidney transplant
History of cancer within 2 years requiring chemotherapy or radiation (except local therapy for non-melanoma skin cancer)
Unstable or worsening heart or lung disease within 6 months before consent
Conditions affecting drug absorption like major stomach or small intestine surgery
Participation in another investigational trial within 30 days or 5 drug half-lives
Medical, psychological, or behavioral issues that may affect safety or study compliance
Contraindications to MRI such as certain pacemakers or implants
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 48 weeks
Participants receive the study drug empagliflozin to target sickle cell-related kidney disease.
Regular visits during treatment period
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Studying Empagliflozin to Prevent Kidney Disease Progression in Adults with Sickle Cell Anemia and Albuminuria
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Published Research Related To This Trial
Effect of dapagliflozin on urinary albumin excretion in patients with chronic kidney disease with and without type 2 diabetes: a prespecified analysis from the DAPA-CKD trial.
Randomised placebo-controlled trial of effect of ramipril on decline in glomerular filtration rate and risk of terminal renal failure in proteinuric, non-diabetic nephropathy. The GISEN Group (Gruppo Italiano di Studi Epidemiologici in Nefrologia).
Effect of Empagliflozin on Kidney Biochemical and Imaging Outcomes in Patients With Type 2 Diabetes, or Prediabetes, and Heart Failure with Reduced Ejection Fraction (SUGAR-DM-HF).
Matthew M Y Lee, Keith A Gillis, Katriona J M Brooksbank...