Empagliflozin in ESKD - A Feasibility Study
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Yoshitsugu Obi, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Mississippi Medical Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Proportion of eligible patients out of screened patientsDuring the screening process
- Success rate of obtaining consent from those eligible patientsDuring the enrollment process
- Proportion of missing doses3 months
The investigators will do pill count using medication bottles and calculate the proportion of missing doses from each patient.
- Proportion of empagliflozin discontinuation3 months
Proportion of participants who discontinue empagliflozin for any reason
- Dropout rate3 months
Proportion of participants who dropped out from the study for any reason
- Length of time on continuous glucose monitoring3 months
Continuous glucose monitoring will be done for up to 14 days.
- Completion rate of timed urine collection3 months
- Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysisImmediately before the first dose
The 1st blood draw for the pharmacokinetic study among patients on peritoneal dialysis
- Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysisAt 30 minutes of the first dose
The 2nd blood draw for the pharmacokinetic study among patients on peritoneal dialysis
- Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysisAt 1 hour of the first dose
The 3rd blood draw for the pharmacokinetic study among patients on peritoneal dialysis
- Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysisAt 1.5 hours of the first dose
The 4th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
- Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysisAt 2 hours of the first dose
The 5th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
- Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysisAt 3 hours of the first dose
The 6th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
- Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysisAt 4 hours of the first dose
The 7th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
- Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysisAt 8 hours of the first dose
The 8th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
- Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysisAt 12 hours of the first dose
The 9th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
- Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysisAt 24 hours of the first dose
The 10th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
- Random blood empagliflozin levelAt Month 1
Time since the last dose will be recorded.
- Random blood empagliflozin levelAt Month 2
Time since the last dose will be recorded.
- Random blood empagliflozin levelAt Month 3
Time since the last dose will be recorded.
- Peritoneal dialysis clearance of empagliflozinAt Month 3
Peritoneal dialysis fluid will be collected for 24 hours.