| Outcome Measures: |
Primary: Change in Extracellular Volume from Baseline to 12 Weeks, Extracellular volume is the sum of the plasma volume and interstitial fluid volume., Baseline, Week 12|Change in Intracellular Volume from Baseline to 12 Weeks, Intracellular volume is the fluid content within the body's cells., Baseline, Week 12|Change in Total Body Water from Baseline to 12 Weeks, Baseline, Week 12|Change in 24-Hour Urine Volume from Baseline to 12 Weeks, Urine volume over a 24-hour period., Baseline, Week 12 | Secondary: Change in 24-Hour Urine Albumin Excretion from Baseline to 12 Weeks, Albumin excreted in the urine over a 24-hour period., Baseline, Week 12|Change in 24-Hour Ambulatory Blood Pressure from Baseline to 12 Weeks, Blood pressure measured over a 24-hour period., Baseline, Week 12|Change in Heart Rate Variability from Baseline to 12 Weeks, Variance in time between the heart beats., 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., 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., 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., Up to Week 12|Incidence of Non-Serious Hypoglycemia, Detected via clinical lab data., 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., Up to Week 12|Incidence of Ketoacidosis, Defined as metabolic state associated with pathologically high serum and urine concentrations of ketone bodies., Up to Week 12|Number of Adverse Events, Up to Week 12|Number of Serious Adverse Events, Up to Week 12 | Other: Recruitment Rate, Defined as average number of patients recruited per month., Up to Week 12|Withdrawal Rate, Defined as percentage of participants who withdraw before completing the trial., Up to Week 12|Percentage of Participants Lost to Follow-Up, Up to Week 12
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| Locations: |
Brigham and Women's Hospital, Boston, Massachusetts, 021215, United States|NYU Langone Health, New York, New York, 10016, United States
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