Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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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 takingSGLT2 inhibitorsACE inhibitorsARBs
Rules you outType 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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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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Status
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 …
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 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
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