Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients

Launched by CHINESE UNIVERSITY OF HONG KONG · Jun 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called empagliflozin, which is usually used for diabetes, to see if it can help patients who are starting peritoneal dialysis (a type of kidney treatment). The goal is to learn if empagliflozin is safe and how it affects kidney function, especially since patients who still produce some urine (known as residual kidney function) tend to have better health outcomes. Participants will be randomly assigned to receive either empagliflozin along with their usual care or just the usual care alone, and the study will last for six months.

To be eligible, participants must be between 18 and 75 years old, have recently started peritoneal dialysis, and have some remaining kidney function. They should also have a known history of type 2 diabetes. However, those with certain conditions, like a history of hemodialysis or severe uncontrolled diabetes, will not be able to participate. Throughout the study, participants will be monitored for their urine output, blood pressure, and how well their blood sugar is controlled, while also checking that the medication is tolerated. If empagliflozin is found to be safe, further studies may follow to explore its benefits in more depth.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Incident PD patients within 90 days of Tenckhoff catheter insertion
• • 2. Age 18-75 years old
• • 3. Know 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