Status:
RECRUITING
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
End Stage Renal Disease on Dialysis
Peritoneal Dialysis Complication
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Diabetes is the leading cause of end stage kidney disease in developed countries. Peritoneal dialysis (PD) is a home-based and cost-effective modality of kidney placement therapy. Maintenance of resid...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients with history of hemodialysis (≥ 3 months) or renal transplant
- Life expectancy \<6 months
- Prior use of any type of SGLT2 inhibitors within 1 month before screening visit
- Poorly controlled diabetes with HBA1c \>11%
- Type 1 diabetes
- History of any active malignancy within 5 years (except curatively resected basal cell or squamous cell skin cancers)
- Peritonitis within 4 weeks
- Ketoacidosis within 5 years
- 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
- Participation in any clinical trial or use of any investigational medicinal product 1 month before screening visit
Key Trial Info
Start Date :
July 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06483074
Start Date
July 29 2024
End Date
October 31 2026
Last Update
August 6 2025
Active Locations (1)
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1
Chinese University of Hong Kong
Hong Kong, Hong Kong