Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06483074

Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients

Led by Chinese University of Hong Kong · Updated on 2025-08-06

48

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Incident peritoneal dialysis patients within 90 days of catheter insertion
  • Age between 18 and 75 years old
  • Patients with or without history of type 2 diabetes
  • Residual glomerular filtration rate greater than 2 ml/min/1.73m2 and urine volume over 400 ml per day
  • Willingness to provide written informed consent
Not Eligible

You will not qualify if you...

  • History of hemodialysis for 3 months or more or renal transplant
  • Life expectancy less than 6 months
  • Use of any SGLT2 inhibitors within 1 month before screening
  • Poorly controlled diabetes with HbA1c over 11%
  • Type 1 diabetes
  • Active malignancy within 5 years except certain skin cancers
  • Peritonitis within 4 weeks
  • Ketoacidosis within 5 years
  • Known allergy to empagliflozin or other SGLT2 inhibitors
  • Any acute or chronic conditions that may affect study compliance
  • Participation in another clinical trial or use of investigational drugs within 1 month before screening

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Chinese University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

J

Jack KC Ng, FRCP

CONTACT

P

Phyllis Cheng, BN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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