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

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.

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