Empagliflozin, a new class of diabetes medication, has demonstrated a reduction in renal function decline among patients with chronic kidney disease, regardless of their diabetes status. However, all previous studies excluded dialysis patients. Patients starting dialysis may still produce a certain amount of urine. Importantly, patients with better preserved residual kidney function tend to have better control of blood pressure and volume status, improved nutrition status, higher quality of life and reduced mortality rate.
The purpose of this study is to learn about the safety of empagliflozin in patients on peritoneal dialysis, in preparation for a future large clinical trial. Participants who newly initiate peritoneal dialysis will be randomly allocated to either empagliflozin on top of standard of care, or standard of care alone. Over a follow-up period of six months, the investigators will collect information on urine volume, blood pressure and glucose control. Safety, tolerability and drug compliance of empagliflozin will also be evaluated. If empagliflozin is found to be safe and well tolerated in patients on peritoneal dialysis, further large-scale randomized controlled trial may be conducted to evaluate its impact on residual kidney function and other relevant clinical outcomes.
Incident PD patients within 90 days of Tenckhoff catheter insertion
Age 18-75 years old
Patient with or without history of Type 2 diabetes
Residual GFR (defined as the average of 24-hour urinary urea and creatinine clearances) > 2ml/min/1.73m2 AND urine volume > 400ml per day
Patients with history of hemodialysis (≥ 3 months) or renal transplant
Life expectancy <6 months
Prior use of any type of SGLT2 inhibitors within 1 month before screening visit
Poorly controlled diabetes with HBA1c >11%
Parallel
Empagliflozin 10 MG
Drugempagliflozin oral 10mg daily for 6 months
Recruitment rate
Number of patients who are randomized each month following the run-in period
Medication adherence
Proportion of prescribed empagliflozin that are taken by the patients (pill counting will be done by investigators at each follow up)
Retention rate
Proportion of patients who have completed the whole study among patients that are randomized
Slope of residual GFR
Residual GFR is calculated as the arithmetic mean of 24-hour urinary urea and creatinine clearances
Time to anuria
Anuria is defined as urine volume \<100ml per day
Difference in residual urine volume
Residual urine volume is measured by 24-hour urine collection
Difference in volume of overhydration
Volume of overhydration is measured by a validated multi-frequency bioimpedance spectroscopy
Change in peritoneal solute transfer rate
This is measured by dialysate-to-plasma creatinine ratio in a standard peritoneal equilibration test (PET)
Difference in frailty status by Clinical Frailty Scale
Clinical Frailty Scale is 9-point scale which is used to quantify the frailty and functional status of dialysis patients. A higher score indicates greater degree of frailty.
Difference in frailty status by Fried frailty phenotype
Fried phenotype consists of five criteria which include both patient-reported domains and objective assessments. Subjects are considered to be frail if they meet three or more criteria.
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