Empagliflozin for End Stage Renal Disease

Safety and Efficacy of Empagliflozin in Hemodialysis

Recruiting Phase 2 Interventional Study
End Stage Renal Disease
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
60 (estimated)
Sponsor
NYU Langone Health · Other
Who this trial is looking for

This trial is looking for adults who are starting hemodialysis for kidney disease. Participants will be given either empagliflozin or a placebo for 12 weeks to see how safe and helpful the drug is.

Are You a Good Fit for This Trial?
Must not be taking SGLT2 inhibitorsACE inhibitorsARBs
Rules you out Type 1 diabetesActive cancerSevere liver diseaseRecent major surgeryRecent amputationSkin ulcers

You may be able to join if

  • I am at least 18 years old.
  • I am on maintenance hemodialysis with some kidney function.
  • I attend hemodialysis three times a week.
  • I can provide consent to join the trial.
  • If I am a woman who can get pregnant, I have a negative pregnancy test.

You may not be able to join if

  • I am unable to provide consent.
  • I do not produce urine.
  • I plan to have a kidney transplant within the next 3 months.
  • I have frequent urinary tract infections.
  • I have severe heart failure.
  • I have had a heart attack or stroke in the past 12 weeks.
  • I have a history of diabetic ketoacidosis.
  • I have liver disease.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Does not …
Contacts

David Charytan, MD, MSc

617-935-1572

David.Charytan@nyulangone.org

CONTACT

Zoe Rimler

212-263-2544

Zoe.Rimler@nyulangone.org

CONTACT