Using empagliflozin to improve kidney function in new peritoneal dialysis patients
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients: a Pilot Randomized Controlled Trial
PHASE2 · Chinese University of Hong Kong · NCT06483074
This study tests if adding a diabetes medication called empagliflozin can help new peritoneal dialysis patients keep their kidney function and improve their overall health.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06483074 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of empagliflozin, a diabetes medication, in patients who have recently started peritoneal dialysis. Participants will be randomly assigned to receive either empagliflozin alongside standard care or standard care alone. The study aims to assess changes in urine volume, blood pressure, and glucose control over a six-month follow-up period. The goal is to determine if empagliflozin can help preserve residual kidney function in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have recently started peritoneal dialysis and have a history of type 2 diabetes.
Not a fit: Patients with a history of hemodialysis or renal transplant, poorly controlled diabetes, or certain acute or chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve kidney function and overall health outcomes for patients on peritoneal dialysis.
How similar studies have performed: While SGLT-2 inhibitors have shown promise in chronic kidney disease populations, this specific application in dialysis patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Incident PD patients within 90 days of Tenckhoff catheter insertion 2. Age 18-75 years old 3. Patient with or without history of Type 2 diabetes 4. Residual GFR (defined as the average of 24-hour urinary urea and creatinine clearances) \> 2ml/min/1.73m2 AND urine volume \> 400ml per day 5. Patients who are willing to provide written informed consent Exclusion Criteria: 1. Patients with history of hemodialysis (≥ 3 months) or renal transplant 2. Life expectancy \<6 months 3. Prior use of any type of SGLT2 inhibitors within 1 month before screening visit 4. Poorly controlled diabetes with HBA1c \>11% 5. Type 1 diabetes 6. History of any active malignancy within 5 years (except curatively resected basal cell or squamous cell skin cancers) 7. Peritonitis within 4 weeks 8. Ketoacidosis within 5 years 9. Known hypersensitivity to empagliflozin or other SGLT2 inhibitors 10. 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 11. Participation in any clinical trial or use of any investigational medicinal product 1 month before screening visit
Where this trial is running
Hong Kong
- Chinese University of Hong Kong — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: Jack KC Ng, FRCP — Chinese University of Hong Kong
- Study coordinator: Jack KC Ng, FRCP
- Email: jackng@cuhk.edu.hk
- Phone: +852 37636098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication, Sodium-glucose Cotransporter-2 Inhibitor, Residual Kidney Function