Actively Recruiting
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
Led by Chinese University of Hong Kong · Updated on 2025-08-06
48
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Incident peritoneal dialysis patients within 90 days of catheter insertion
- Age between 18 and 75 years old
- Patients with or without history of type 2 diabetes
- Residual glomerular filtration rate greater than 2 ml/min/1.73m2 and urine volume over 400 ml per day
- Willingness to provide written informed consent
You will not qualify if you...
- History of hemodialysis for 3 months or more or renal transplant
- Life expectancy less than 6 months
- Use of any SGLT2 inhibitors within 1 month before screening
- Poorly controlled diabetes with HbA1c over 11%
- Type 1 diabetes
- Active malignancy within 5 years except certain skin cancers
- Peritonitis within 4 weeks
- Ketoacidosis within 5 years
- Known allergy to empagliflozin or other SGLT2 inhibitors
- Any acute or chronic conditions that may affect study compliance
- Participation in another clinical trial or use of investigational drugs within 1 month before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
J
Jack KC Ng, FRCP
CONTACT
P
Phyllis Cheng, BN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here