Actively Recruiting
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients: a Pilot Randomized Controlled Trial
Led by Chinese University of Hong Kong · Updated on 2025-08-06
48
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of empagliflozin, a diabetes medication, in patients who have recently started peritoneal dialysis, a treatment for end-stage kidney disease. This study focuses on patients who still produce some urine despite dialysis, as preserving residual kidney function can improve blood pressure control, nutrition, quality of life, and survival. The study is a phase 2 randomized controlled trial aiming to prepare for a larger future trial by assessing safety and feasibility. Participants will be randomly assigned to one of two groups: one receiving oral empagliflozin 10 mg daily plus standard care including optimized doses of RAAS inhibitors, and the other receiving standard care alone with optimized RAAS inhibitors. Before randomization, there is a 6 to 8 week run-in period to adjust RAAS inhibitor doses. The treatment period lasts 6 months, during which the effects on kidney function and related health measures will be studied. Throughout the study, participants will have their urine volume, blood pressure, glucose control, and signs of infection monitored at multiple time points. The study will also assess medication adherence, retention rates, and safety outcomes like infections and ketoacidosis. Information collected will help determine if empagliflozin is safe and well tolerated for patients on peritoneal dialysis and support the design of a larger trial. Total participation time includes the run-in and 6-month treatment phases.
CONDITIONS
Brief 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 Tenckhoff catheter insertion
- Age between 18 and 75 years old
- Patients with or without history of Type 2 diabetes
- Residual glomerular filtration rate above 2 ml/min/1.73m2 and urine volume greater than 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 previous renal transplant
- Life expectancy less than 6 months
- Use of any SGLT2 inhibitors within 1 month before screening
- Poorly controlled diabetes with HbA1c above 11%
- Diagnosis of Type 1 diabetes
- Active malignancy within the past 5 years except certain skin cancers
- Peritonitis within 4 weeks before screening
- Ketoacidosis within the past 5 years
- Known allergy or hypersensitivity to empagliflozin or other SGLT2 inhibitors
- Any active physical or mental condition that may affect study compliance
- Participation in another clinical trial or use of investigational medicines within 1 month before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 8 weeks
Participants undergo a run-in period where the dose of RAAS inhibitors is increased to the maximally tolerated dose.
Visits as needed to optimize RAAS inhibitor dose
Duration - 6 months
Participants are randomized to receive oral empagliflozin 10 mg daily on top of optimized RAAS inhibitor dose or optimized RAAS inhibitor alone for 6 months to assess preservation of residual kidney function.
Visits at Month 0, 1, 2, 4, and 6 for assessments
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
P
Phyllis Cheng, BN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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