NCT06483074RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients: a Pilot Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 23 Jun 2024
- Start date
- 29 Jul 2024
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Chronic kidney disease
- NCT number
- NCT06483074
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 48
- From 29 Jul 2024 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Poorly controlled diabetes with HBA1c \>11%
Other
- Life expectancy \<6 months
- Peritonitis within 4 weeks
- Ketoacidosis within 5 years
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.