Kidney Functional Magnetic Resonance Imaging and Change in eGFR in Individuals with CKD.
Anand Srivastava, Xuan Cai, Jungwha Lee...
https://pubmed.ncbi.nlm.nih.gov/32345747Actively Recruiting
Phase 2
Age: 18Years - 60Years
All Genders
ID07175051
Targeting the Pathophysiology of Sickle Cell-Related Kidney Disease Using the SGLT2 Inhibitor Empagliflozin
Led by University of Illinois at Chicago · Updated on 2026-05-19
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
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 drug's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
University of Illinois Chicago, Sickle Cell Center
Chicago, Illinois, United States, 60302
Actively Recruiting
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Research Team
S
Santosh L Saraf, MD
A
Anand Srivastave, MD
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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Andrew S Levey, Lesley A Stevens, Christopher H Schmid...
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