Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1499
Source ID: NCT05715814
Associated Drug: Empagliflozin 25 Mg
Title: meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis
Acronym: CANARY
Status: RECRUITING
Study Results: NO
Results:
Conditions: Peritoneal Dialysis Complication|End Stage Kidney Disease|Sodium-glucose Co-transporter-2 Inhibitors|Kidney Dysfunction|Residual Kidney Function
Interventions: DRUG: Empagliflozin 25 MG
Outcome Measures: Primary: Change in measured GFR, GFR will be determined from the average of creatinine and urea clearance from a 24-hour urine collection., Before and 2 weeks after initiation of empagliflozin. | Secondary: 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., 2 weeks|Change in ultrafiltration volume, 2 weeks|Change in fraction of glucose remaining in the dialysate, 2 weeks|Change in dialysate/plasma creatinine, 2 weeks|Change in dialysate/plasma urea, 2 weeks|Change in sodium dialysate concentration, 2 weeks|Change in glycated hemoglobin (HbA1c), 2 weeks|Change in systolic and diastolic blood pressure, 2 weeks|Change in body weight, 2 weeks|Change in body composition (percent body mass, body fat, and muscle mass), Bioimpedence measurements will be taken to study the effects of intervention on body composition., 2 weeks|Change in fractional urine excretion of sodium, Urinary analysis will be performed to quantify the amount of sodium excretion., 2 weeks|Change in fractional urine excretion of glucose, Urinary analysis will be performed to quantify the amount of glucose excretion., 2 weeks|Change in eGFRβ2-microglobulin, Blood sample analysis to assess middle molecule clearance., 2 weeks|Change in degree of albuminuria, Urinary analysis will be performed to determine if there has been any change in the severity of albuminuria, 2 weeks|Change in BNP (NT-proB-type Natriuretic Peptide), 2 weeks|Change in markers of neurohumoral activation, erythropoiesis, and inflammation., 2 weeks|The safety of empaglifllozin use in PD patients with RKF with regard to anuria (<100cc/day), volume depletion, diabetic ketoacidosis, genito-urinary infections, PD peritonitis and death will be evaluated., 2 weeks
Sponsor/Collaborators: Sponsor: University Health Network, Toronto
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-12-01
Results First Posted:
Last Update Posted: 2025-01-31
Locations: Toronto General Hospital, Toronto, Ontario, M5G2N2, Canada
URL: https://clinicaltrials.gov/show/NCT05715814