Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients

Recruiting now · Phase 2

Conditions studied: End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication, Sodium-glucose Cotransporter-2 Inhibitor, Residual Kidney Function

In brief

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.

Key facts

Study ID

NCT06483074

Run by

Chinese University of Hong Kong

People needed

48

Starts

2024-07-29

Expected to finish

2026-10-31

Last updated by the study team

2025-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%
• Type 1 diabetes
• History of any active malignancy within 5 years (except curatively resected basal cell or squamous cell skin cancers)
• Peritonitis within 4 weeks
• Ketoacidosis within 5 years
• 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
• Participation in any clinical trial or use of any investigational medicinal product 1 month before screening visit

Where it is running

• Chinese University of Hong Kong — Hong Kong, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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