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Empagliflozin for End-Stage Kidney Disease on Hemodialysis

This study is looking at empagliflozin, a medication taken as a pill once a day for 12 weeks, for people with end-stage kidney disease who are on hemodialysis. We want to see if empagliflozin is safe and how well it works compared to a placebo (a pill with no medicine). You might be able to join if you are an adult (18 or older) on hemodialysis three times a week and still produce some urine. The study will measure changes in body water to see if the treatment is effective. The study is currently recruiting 60 participants.

Study design
This is a Phase 2, randomized, double-blind, placebo-controlled study involving 60 participants.
What's involved
You would take a pill (either empagliflozin or placebo) once daily for 12 weeks. Measurements will be taken at the beginning and at Week 12.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks, with measurements taken at the beginning and at Week 12.

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NCT05786443

Safety and Efficacy of Empagliflozin in Hemodialysis

Recruiting
PHASE2Ages 18+InterventionalPrevention
NYU Langone Health
~60 participants
Updated 2025-12-04 on ClinicalTrials.gov
What's tested:Empagliflozin 10 MGPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Extracellular Volume from Baseline to 12 Weeks
Measured over Baseline, Week 12
+3 more outcomes measured

Conditions

End Stage Renal Disease

Explore related trials

Chronic Kidney Disease, Stage 5

Where it's being run

2 sites across 2 states
Massachusetts1
New York1

Study leadership

  • David Charytan, MS, MSc · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

David Charytan, MD, MSc
[email protected]
617-935-1572
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults ≥18 years on maintenance hemodialysis (HD) with residual kidney function
Thrice-weekly HD
Willingness and capacity to provide informed consent
For women of childbearing potential, a negative pregnancy test is required at screening

Exclusion

Does not have capacity to consent
Anuria (daily urine volume \< 200 mL/day)
Planned kidney transplant within 3 months
Recurrent urinary tract infections (\>2 episodes/year or antibiotic prophylaxis)
New York Heart Association (NYHA) Class IV heart failure (HF)
Myocardial infarction, unstable angina, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 12 weeks
History of diabetic ketoacidosis
Type 1 Diabetes Mellitus
Hereditary glucose-galactose malabsorption or primary renal glucosuria
Liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis); Alanine aminotransferase (ALT) levels \>2.0 times the upper limit of normal (ULN) or total bilirubin \>1.5 times the ULN, unless consistent with Gilbert's disease
Active malignancy (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ) defined as malignancy under active treatment with chemotherapy, radiation or immunotherapy, or being treated as palliative.
Major surgery within 12 weeks
Atraumatic amputation within past 12 months of screening, or an active skin ulcer, osteomyelitis, gangrene, or critical ischemia of the lower extremity within 6 months of screening
Combination use of angiotensin-converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB)
Current use of an SGLT2 inhibitor (within 6 weeks prior to randomization)
Known allergies, hypersensitivity, or intolerance to SGLT2i or its excipients
Received an active investigational drug (including vaccines) other than a placebo agent, or used an investigational medical device within 12 weeks before Day 1/baseline
Pregnant or breast-feeding or planning to become pregnant or breast-feed during the study
Women of childbearing potential not willing to use a highly-effective method(s) of birth control, or who are unwilling or unable to be tested for pregnancy.
Any condition that in the opinion of the investigator would make participation not in the best interest of the subject

What this trial measures

  • Change in Extracellular Volume from Baseline to 12 WeeksBaseline, Week 12

    Extracellular volume is the sum of the plasma volume and interstitial fluid volume.

  • Change in Intracellular Volume from Baseline to 12 WeeksBaseline, Week 12

    Intracellular volume is the fluid content within the body's cells.

  • Change in Total Body Water from Baseline to 12 WeeksBaseline, Week 12
  • Change in 24-Hour Urine Volume from Baseline to 12 WeeksBaseline, Week 12

    Urine volume over a 24-hour period.