Recruiting
Phase 2

Empagliflozin

Sponsor:

NYU Langone Health

Code:

NCT05786443

Conditions

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Empagliflozin 10 MG

Placebo

Study Details

Brief summary:

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.

Conditions

End Stage Renal Disease

Study ID

NCT05786443

Start date

Jan 31, 2024

Status verified date

Dec, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Empagliflozin

Participants with end-stage kidney disease (ESRD) initiating hemodialysis will receive Empagliflozin 10 mg daily for 12 weeks.

placebo comparator: Placebo

Participants with ESRD initiating hemodialysis will receive Empagliflozin-matching placebo daily for 12 weeks.

Interventions

Empagliflozin 10 MG

Sodium glucose cotransporter 2 inhibitor (SGLT2i) dosed once-daily over 12 weeks. Administered as oral tablet.

Placebo

Empagliflozin-matching placebo dosed once-daily over 12 weeks. Administered as oral tablet.

Primary outcome measure

  • Change in Extracellular Volume from Baseline to 12 Weeks [ Time Frame: Baseline, Week 12 ]
  • Change in Intracellular Volume from Baseline to 12 Weeks [ Time Frame: Baseline, Week 12 ]
  • Change in Total Body Water from Baseline to 12 Weeks [ Time Frame: Baseline, Week 12 ]
  • Change in 24-Hour Urine Volume from Baseline to 12 Weeks [ Time Frame: Baseline, Week 12 ]

Central Contacts and Locations

Central contacts

David Charytan, MD, MSc

617-935-1572David.Charytan@nyulangone.org

Zoe Rimler

212-263-2544Zoe.Rimler@nyulangone.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 021215

Contacts

Finnian R. Mc Causland

617-732-6432fmccausland@bwh.harvard.edu

Principal Investigator:

Finnian R. Mc Causland

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Principal Investigator:

David M Charytan, MS, MSc

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-04.