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RECRUITING
NCT06483074
PHASE2

Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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 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.

Official title: Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients: a Pilot Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-07-29

Completion Date

2026-10-31

Last Updated

2025-08-06

Healthy Volunteers

No

Interventions

DRUG

Empagliflozin 10 MG

empagliflozin oral 10mg daily for 6 months

Locations (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong