NCT05786443RecruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Empagliflozin Among Patients Initiating Hemodialysis for the Treatment of End-Stage Kidney Disease
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 15 Mar 2023
- Start date
- 31 Jan 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- NYU Langone Health
- Diseases
- Chronic kidney disease
- NCT number
- NCT05786443
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 31 Jan 2024 to the primary completion date, 30 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned kidney transplant within 3 months
- 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
- 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)
- 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
Other illness
- 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
- 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
- Known allergies, hypersensitivity, or intolerance to SGLT2i or its excipients
- Any condition that in the opinion of the investigator would make participation not in the best interest of the subject
Lab values
- 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
Other
- Does not have capacity to consent
- Anuria (daily urine volume \< 200 mL/day)
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.