Can a diabetes drug help dialysis patients manage fluid buildup?
NCT ID NCT05786443
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether empagliflozin, a diabetes medicine, is safe and helps control body fluid levels in 60 adults who are starting hemodialysis for end-stage kidney disease. Participants will take either empagliflozin or a placebo for 12 weeks. The goal is to see if the drug improves fluid balance and blood pressure without causing harm.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 021215, United States
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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