Actively Recruiting
Safety and Efficacy of Empagliflozin in Hemodialysis
Led by NYU Langone Health · Updated on 2025-12-04
60
Participants Needed
2
Research Sites
152 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
A 12-week, phase II, randomized, double-blind, placebo-controlled, multi-center study to assess the safety, tolerability, and preliminary efficacy of empagliflozin versus placebo among patients initiating hemodialysis (n=60) for the treatment of end-stage kidney disease.
CONDITIONS
Official Title
Safety and Efficacy of Empagliflozin in Hemodialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 218 years on maintenance hemodialysis (HD) with residual kidney function
- Receiving hemodialysis three times per week
- Willing and able to provide informed consent
- Women of childbearing potential must have a negative pregnancy test at screening
You will not qualify if you...
- Unable to provide informed consent
- Anuria (daily urine volume less than 200 mL)
- Planned kidney transplant within 3 months
- Recurrent urinary tract infections (more than 2 episodes per year or on antibiotic prophylaxis)
- New York Heart Association (NYHA) Class IV heart failure
- Recent myocardial infarction, unstable angina, revascularization procedure, or stroke within 12 weeks
- History of diabetic ketoacidosis
- Type 1 Diabetes Mellitus
- Hereditary glucose-galactose malabsorption or primary renal glucosuria
- Liver disease with elevated liver enzymes or bilirubin unless Gilbert's disease
- Active malignancy under active treatment or palliative care (except certain skin and cervical cancers)
- Major surgery within 12 weeks
- Recent amputation, active skin ulcer, osteomyelitis, gangrene, or critical ischemia of the lower extremity
- Use of both ACE inhibitors and angiotensin receptor blockers
- Use of SGLT2 inhibitors within 6 weeks before baseline
- Known allergies or intolerance to SGLT2 inhibitors
- Use of active investigational drugs or devices within 12 weeks before baseline
- Pregnant or breastfeeding or planning pregnancy or breastfeeding during the study
- Women not willing to use effective birth control or unable to test for pregnancy
- Any condition that would make participation unsafe or not in the participant's best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 021215
Actively Recruiting
2
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
D
David Charytan, MD, MSc
CONTACT
Z
Zoe Rimler
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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