Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese University of Hong Kong

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

Treatment groups

48 Participants
are divided into 2 treatment groups