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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
Sodium glucose cotransporter 2 inhibitor (SGLT2i) dosed once-daily over 12 weeks. Administered as oral tablet.
Empagliflozin-matching placebo dosed once-daily over 12 weeks. Administered as oral tablet.
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGChange in Extracellular Volume from Baseline to 12 Weeks
Extracellular volume is the sum of the plasma volume and interstitial fluid volume.
Time frame: Baseline, Week 12
Change in Intracellular Volume from Baseline to 12 Weeks
Intracellular volume is the fluid content within the body's cells.
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
Urine volume over a 24-hour period.
Time frame: Baseline, Week 12
Change in 24-Hour Urine Albumin Excretion from Baseline to 12 Weeks
Albumin excreted in the urine over a 24-hour period.
Time frame: Baseline, Week 12
Change in 24-Hour Ambulatory Blood Pressure from Baseline to 12 Weeks
Blood pressure measured over a 24-hour period.
Time frame: Baseline, Week 12
Change in Heart Rate Variability from Baseline to 12 Weeks
Variance in time between the heart beats.
Time frame: Baseline, Week 12
Incidence of Intra-Dialytic Hypotension
Intra-dialytic hypotension defined as nadir systolic blood pressure (SBP) \<90 mmHg if pre-HD SBP≤160 mmHg, or nadir SBP \<100 mmHg if pre-HD SBP \>160 mmHg.
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Time frame: Up to Week 12
Incidence of Inter-Dialytic Hypotension
Inter-dialytic hypotension defined symptomatic SBP \<90 mmHg or hypotension requiring adjustment in blood pressure medications or treatment in an emergency or hospitalized setting.
Time frame: Up to Week 12
Incidence of Serious Hypotension
Defined as hypotension requiring hospitalization, emergency room (ER) visit, or reduction of blinded study medication or other anti-hypertensive medications.
Time frame: Up to Week 12
Incidence of Non-Serious Hypoglycemia
Detected via clinical lab data.
Time frame: Up to Week 12
Incidence of Serious Hypoglycemia
Defined as hypoglycemia requiring hospitalization, emergency room (ER) visit or the combination of glucose\<70 mg/dL and urgent glucagon or carbohydrate use.
Time frame: Up to Week 12
Incidence of Ketoacidosis
Defined as metabolic state associated with pathologically high serum and urine concentrations of ketone bodies.
Time frame: Up to Week 12
Number of Adverse Events
Time frame: Up to Week 12
Number of Serious Adverse Events
Time frame: Up to Week 12