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Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients

RecruitingPhase 2Ages 18 Years - 75 YearsAllChinese University of Hong Kong
NCT06483074 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 investigato

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📋 Eligibility rules (as published)
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
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What it tests

  • Empagliflozin 10 MG
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Where

1 site
Chinese University of Hong Kong
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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