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
Overview
- Phase
- Phase 2
- Intervention
- Empagliflozin 10 MG
- Conditions
- End Stage Renal Disease
- Sponsor
- NYU Langone Health
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in Total Body Water from Baseline to 12 Weeks
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
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 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
Arms & Interventions
Empagliflozin
Participants with end-stage kidney disease (ESRD) initiating hemodialysis will receive Empagliflozin 10 mg daily for 12 weeks.
Intervention: Empagliflozin 10 MG
Placebo
Participants with ESRD initiating hemodialysis will receive Empagliflozin-matching placebo daily for 12 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Total Body Water from Baseline to 12 Weeks
Time Frame: Baseline, Week 12
Change in Extracellular Volume from Baseline to 12 Weeks
Time Frame: Baseline, Week 12
Extracellular volume is the sum of the plasma volume and interstitial fluid volume.
Change in Intracellular Volume from Baseline to 12 Weeks
Time Frame: Baseline, Week 12
Intracellular volume is the fluid content within the body's cells.
Change in 24-Hour Urine Volume from Baseline to 12 Weeks
Time Frame: Baseline, Week 12
Urine volume over a 24-hour period.
Secondary Outcomes
- Change in 24-Hour Urine Albumin Excretion from Baseline to 12 Weeks(Baseline, Week 12)
- Change in 24-Hour Ambulatory Blood Pressure from Baseline to 12 Weeks(Baseline, Week 12)
- Change in Heart Rate Variability from Baseline to 12 Weeks(Baseline, Week 12)
- Incidence of Intra-Dialytic Hypotension(Up to Week 12)
- Incidence of Inter-Dialytic Hypotension(Up to Week 12)
- Incidence of Serious Hypotension(Up to Week 12)
- Incidence of Non-Serious Hypoglycemia(Up to Week 12)
- Incidence of Serious Hypoglycemia(Up to Week 12)
- Incidence of Ketoacidosis(Up to Week 12)
- Number of Adverse Events(Up to Week 12)
- Number of Serious Adverse Events(Up to Week 12)