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Clinical Trial Details

Trial ID: L1263
Source ID: NCT05687058
Associated Drug: Empagliflozin 25 Mg Thrice-Weekly Post-Hemodialysis Dosing
Title: Empagliflozin in ESKD - A Feasibility Study
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic|Heart Failure
Interventions: DRUG: Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing|DRUG: Empagliflozin 10 mg daily dosing
Outcome Measures: Primary: Proportion of eligible patients out of screened patients, During the screening process|Success rate of obtaining consent from those eligible patients, During the enrollment process|Proportion of missing doses, The investigators will do pill count using medication bottles and calculate the proportion of missing doses from each patient., 3 months|Proportion of empagliflozin discontinuation, Proportion of participants who discontinue empagliflozin for any reason, 3 months|Dropout rate, Proportion of participants who dropped out from the study for any reason, 3 months|Length of time on continuous glucose monitoring, Continuous glucose monitoring will be done for up to 14 days., 3 months|Completion rate of timed urine collection, 3 months|Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis, The 1st blood draw for the pharmacokinetic study among patients on peritoneal dialysis, Immediately before the first dose|Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis, The 2nd blood draw for the pharmacokinetic study among patients on peritoneal dialysis, At 30 minutes of the first dose|Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis, The 3rd blood draw for the pharmacokinetic study among patients on peritoneal dialysis, At 1 hour of the first dose|Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis, The 4th blood draw for the pharmacokinetic study among patients on peritoneal dialysis, At 1.5 hours of the first dose|Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis, The 5th blood draw for the pharmacokinetic study among patients on peritoneal dialysis, At 2 hours of the first dose|Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis, The 6th blood draw for the pharmacokinetic study among patients on peritoneal dialysis, At 3 hours of the first dose|Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis, The 7th blood draw for the pharmacokinetic study among patients on peritoneal dialysis, At 4 hours of the first dose|Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis, The 8th blood draw for the pharmacokinetic study among patients on peritoneal dialysis, At 8 hours of the first dose|Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis, The 9th blood draw for the pharmacokinetic study among patients on peritoneal dialysis, At 12 hours of the first dose|Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis, The 10th blood draw for the pharmacokinetic study among patients on peritoneal dialysis, At 24 hours of the first dose|Random blood empagliflozin level, Time since the last dose will be recorded., At Month 1|Random blood empagliflozin level, Time since the last dose will be recorded., At Month 2|Random blood empagliflozin level, Time since the last dose will be recorded., At Month 3|Peritoneal dialysis clearance of empagliflozin, Peritoneal dialysis fluid will be collected for 24 hours., At Month 3 | Secondary: Number of Participants with Hepatic injury, defined by an elevation of AST and/or ALT \>3-fold upper limit of normal (ULN) combined with an elevation of total bilirubin \>2-fold ULN measured, and/or marked peak aminotransferase (ALT and/or AST) elevations ≥5-fold ULN, 3 months|Number of Participants with Ketoacidosis, defined by elevated serum beta hydroxybutyrate ≥3.0 mmol/L, 3 months|Number of Participants with Lower limb amputation, defined by any non-trauma-related event leading to a lower limb procedure of amputation, auto-amputation or disarticulation, 3 months|Number of Participants with Symptomatic urinary tract infection, defined by symptoms consistent with urinary tract infection plus pyuria and bacteriuria - urine culture sample has to be taken and sent to central lab for confirmation of the diagnosis, 3 months|Number of Participants with genital infection, per patient report, 3 months|Number of Participants with Tinea cruris, per patient report, 3 months|Number of Participants with Nausea, per patient report, 3 months|Number of Participants with Vomiting, per patient report, 3 months|Number of Participants with Skin and soft tissue infection, per patient report, 3 months|Days on continuous glucose monitoring (CGM), Per CGM report, Run in (within one month prior to the study start)|Days on continuous glucose monitoring (CGM), Per CGM report, At Month 0|Days on continuous glucose monitoring (CGM), Per CGM report, At Month 2|% Time of active CGM, Per CGM report, Run in (within one month prior to the study start)|% Time of active CGM, Per CGM report, At Month 0|% Time of active CGM, Per CGM report, At Month 2|Average glucose, Per CGM report, Run in (within one month prior to the study start)|Average glucose, Per CGM report, At Month 0|Average glucose, Per CGM report, At Month 2|Glucose management indicator (estimated A1C level based on the average glucose level from CGM readings for 14 or more days), Per CGM report, Run in (within one month prior to the study start)|Glucose management indicator (estimated A1C level based on the average glucose level from CGM readings for 14 or more days), Per CGM report, At Month 0|Glucose management indicator (estimated A1C level based on the average glucose level from CGM readings for 14 or more days), Per CGM report, At Month 2|Glucose variability, Per CGM report, Run in (within one month prior to the study start)|Glucose variability, Per CGM report, At Month 0|Glucose variability, Per CGM report, At Month 2|Time in very high range (%), Percent time for plasma glucose \>250 mg/dL, Run in (within one month prior to the study start)|Time in very high range (%), Percent time for plasma glucose \>250 mg/dL, At Month 0|Time in very high range (%), Percent time for plasma glucose \>250 mg/dL, At Month 2|Time in high range (%), Percent time for plasma glucose \>180 to 250 mg/dL, Run in (within one month prior to the study start)|Time in high range (%), Percent time for plasma glucose \>180 to 250 mg/dL, At Month 0|Time in high range (%), Percent time for plasma glucose \>180 to 250 mg/dL, At Month 2|Time in target range (%), Percent time for plasma glucose \>70 to 180 mg/dL, Run in (within one month prior to the study start)|Time in target range (%), Percent time for plasma glucose \>70 to 180 mg/dL, At Month 0|Time in target range (%), Percent time for plasma glucose \>70 to 180 mg/dL, At Month 2|Time in low range (%), Percent time for plasma glucose \>54 to 70 mg/dL, Run in (within one month prior to the study start)|Time in low range (%), Percent time for plasma glucose \>54 to 70 mg/dL, At Month 0|Time in low range (%), Percent time for plasma glucose \>54 to 70 mg/dL, At Month 2|Time in very low range (%), Percent time for plasma glucose 54 mg/dL or lower, Run in (within one month prior to the study start)|Time in very low range (%), Percent time for plasma glucose 54 mg/dL or lower, At Month 0|Time in very low range (%), Percent time for plasma glucose 54 mg/dL or lower, At Month 2|Number of Participants with Hypoglycemia levels 1, Plasma glucose \<70 mg/dL for ≥15 minutes, Run in (within one month prior to the study start)|Number of Participants with Hypoglycemia levels 1, Plasma glucose \<70 mg/dL for ≥15 minutes, At Month 0|Number of Participants with Hypoglycemia levels 1, Plasma glucose \<70 mg/dL for ≥15 minutes, At Month 2|Number of Participants with Hypoglycemia levels 2, Plasma glucose \<54 mg/dL for ≥15 minutes, Run in (within one month prior to the study start)|Number of Participants with Hypoglycemia levels 2, Plasma glucose \<54 mg/dL for ≥15 minutes, At Month 0|Number of Participants with Hypoglycemia levels 2, Plasma glucose \<54 mg/dL for ≥15 minutes, At Month 2|Number of Participants with Prolonged hypoglycemia, Plasma glucose \<54 mg/dL for ≥2.0 hours, Run in (within one month prior to the study start)|Number of Participants with Prolonged hypoglycemia, Plasma glucose \<54 mg/dL for ≥2.0 hours, At Month 0|Number of Participants with Prolonged hypoglycemia, Plasma glucose \<54 mg/dL for ≥2.0 hours, At Month 2|Changes from baseline to Month 3 in left ventricular end-diastolic volume, To be evaluated by transthoracic echocardiogram (optional), 3 months|Changes from baseline to Month 3 in left ventricular end-systolic volume, To be evaluated by transthoracic echocardiogram (optional), 3 months|Changes from baseline to Month 3 in left ventricular mass index, To be evaluated by transthoracic echocardiogram (optional), 3 months|Changes from baseline to Month 3 in left ventricular ejection fraction, To be evaluated by transthoracic echocardiogram (optional), 3 months|Changes from baseline to Month 3 in left ventricular diastolic function, To be evaluated by transthoracic echocardiogram (optional), 3 months|Changes from baseline to Month 3 in longitudinal global strain, To be evaluated by transthoracic echocardiogram (optional), 3 months|Changes from baseline to Month 3 in radial global strain, To be evaluated by transthoracic echocardiogram (optional), 3 months|Changes from baseline to Month 3 in circumferential global strain, To be evaluated by transthoracic echocardiogram (optional), 3 months|Changes from baseline to Month 3 in home systolic blood pressure, 3 months|Changes from baseline to Month 3 in home diastolic blood pressure, 3 months|Changes from baseline to Month 3 in Kidney Disease Quality of Life (KDQOL)-36 questionnaire, Details are available at the URL below. https://www.rand.org/content/dam/rand/www/external/health/surveys_tools/kdqol/kdqol36.pdf, 3 months|Changes from baseline to Month 3 in residual kidney function, Renal urea clearance, 3 months|Changes from baseline to Month 3 in hemoglobin, 3 months|Changes from baseline to Month 3 in erythropoiesis stimulating drug dose, 3 months|Hospitalization/Emergency room visit rate for heart failure, 3 months|Cardiovascular mortality, 3 months|All-cause mortality, 3 months|Changes Estimated glomerular filtration rate (GFR) from baseline to Month 3, Estimated by Cystatin C and beta-2 macroglobulin, 3 months | Other: Semi-structured interview, The results would be qualitative and provide data that are needed to improve the enrollment efficiency and protocol adherence. This will be done by tracking eligible screened patients who then go on to participate in the study as well as overall participant compliance with study procedures., 3 months
Sponsor/Collaborators: Sponsor: University of Mississippi Medical Center
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2025-07-31
Results First Posted:
Last Update Posted: 2024-09-19
Locations: University of Mississippi Medical Center, Jackson, Mississippi, 39157, United States|Jackson Medicall Mall Dialysis Clinic, Jackson, Mississippi, 39213, United States
URL: https://clinicaltrials.gov/show/NCT05687058