About this trial
The primary aim of this study is to determine the safety and mechanisms of SGLT2 inhibition in individuals on peritoneal dialysis (PD) with residual kidney function (RKF).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed and dated written informed consent.
Patients aged ≥18 years on PD with RKF defined as at least 250 cc of urine output per day (assessed via 24-hour urine collection) and a minimum measured GFR of 2 ml/min/1.73m2, as measured at least once in the last 3 months.
Stable PD prescription, as determined by investigators.
Stable dose of RAAS blockade if on a medication within this class for the last 30 days.
Disqualifiers
Type 1 diabetes.
Recent (in the 30 days prior to screening) acute coronary syndrome or cerebrovascular event.
PD peritonitis within 30 days of screening.
History of organ transplant, including pancreas, pancreatic islet cells or kidney transplant.
Trial design
Single group
Treatments tested in this trial
Empagliflozin 25 MG
DrugPO once daily
Treatment groups
Trial outcomes
Primary outcomes
Change in measured GFR
GFR will be determined from the average of creatinine and urea clearance from a 24-hour urine collection.
Secondary outcomes
Rebound in GFR after Cessation of Therapy
A GFR measurement will be performed 2 weeks after cessation of empagliflozin, with the aim of capturing the reversible "rebound" in GFR after cessation of therapy.
Change in ultrafiltration volume
Change in fraction of glucose remaining in the dialysate
Change in dialysate/plasma creatinine
Sponsors and contacts
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