About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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%
Trial design
Treatments tested in this trial
- Empagliflozin 10 MG