Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients

Sponsor
Chinese University of Hong Kong
Study ID
NCT06483074
Phase
PHASE2
Status
Recruiting
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Conditions

  • End Stage Renal Disease on Dialysis
  • Peritoneal Dialysis Complication
  • Residual Kidney Function
  • Sodium-glucose Cotransporter-2 Inhibitor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 29, 2024
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Recruitment rate [ Time Frame: During randomization ]

Central Contacts

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