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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hong Kong Special Administrative Region
Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Jack KC Ng, FRCP
jackng@cuhk.edu.hk
+852 37636098
Backup
Phyllis Cheng, BN
pcheng809@yahoo.com.hk
+852 35053528
Time Frame
Start Date: 2024-07-29
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 48
Treatments
Active_comparator: Intervention group
Patients randomized to intervention group will receive oral empagliflozin 10mg daily on top of optimized dose of RAAS inhibitor for 6 months
No_intervention: Control group
Patients randomized to control group will receive optimized dose of RAAS inhibitor for 6 months
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov