Condition: End Stage Renal Disease on Dialysis · Peritoneal Dialysis Complication · Sodium-glucose Cotransporter-2 Inhibitor · Sponsor: Chinese University of Hong Kong
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.
This description comes directly from the study's public registry record.
Jack KC Ng, FRCP · +852 37636098 · jackng@cuhk.edu.hk
Phyllis Cheng, BN · +852 35053528 · pcheng809@yahoo.com.hk
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| Chinese University of Hong Kong | Hong Kong, Hong Kong | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06483074