Tests empagliflozin for kidney function in people starting peritoneal dialysis
Tests empagliflozin, a diabetes drug, in adults newly starting peritoneal dialysis for kidney failure.
Plain-language title generated from the registry record
Registry title: Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
Key facts
- Where
- Hong Kong, Hong KongSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06483074, who can take part
Where in Hong Kong
- Chinese University of Hong KongHong Kong, Hong KongTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese University of Hong Kong
- Trial code
- NCT06483074
- Record updated
- 22 October 2026
- Original description
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.Read full original descriptionShow less
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients: a Pilot Randomized Controlled 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.
Inclusion: 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 who are willing to provide written informed consent.
Exclusion: Prior use of any type of SGLT2 inhibitors within 1 month before screening visit; Participation in any clinical trial or use of any investigational medicinal product 1 month before screening visit; Patients with history of hemodialysis (≥ 3 months) or renal transplant; Type 1 diabetes; History of any active malignancy within 5 years (except curatively resected basal cell or squamous cell skin cancers); Known hypersensitivity to empagliflozin or other SGLT2 inhibitors; Any active acute or chronic physical or mental conditions that, in the opinion of the investigator, might interfere with the compliance of participants to or the performance of this study; Poorly controlled diabetes with HBA1c >11%; Life expectancy <6 months; Peritonitis within 4 weeks; Ketoacidosis within 5 years.