Using empagliflozin to improve kidney function in new peritoneal dialysis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and efficacy of empagliflozin, a diabetes medication, in patients who have recently started peritoneal dialysis. Participants will be randomly assigned to receive either empagliflozin alongside standard care or standard care alone. The study aims to assess changes in urine volume, blood pressure, and glucose control over a six-month follow-up period. The goal is to determine if empagliflozin can help preserve residual kidney function in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Incident PD patients within 90 days of Tenckhoff catheter insertion
2. Age 18-75 years old
3. Patient with or without history of Type 2 diabetes
4. Residual GFR (defined as the average of 24-hour urinary urea and creatinine clearances) \> 2ml/min/1.73m2 AND urine volume \> 400ml per day
5. Patients who are willing to provide written informed consent

Exclusion Criteria:

1. Patients with history of hemodialysis (≥ 3 months) or renal transplant
2. Life expectancy \<6 months
3. Prior use of any type of SGLT2 inhibitors within 1 month before screening visit
4. Poorly controlled diabetes with HBA1c \>11%
5. Type 1 diabetes
6. History of any active malignancy within 5 years (except curatively resected basal cell or squamous cell skin cancers)
7. Peritonitis within 4 weeks
8. Ketoacidosis within 5 years
9. Known hypersensitivity to empagliflozin or other SGLT2 inhibitors
10. Any active acute or chronic physical or mental conditions that, in the opinion of the investigator, might interfere with the compliance of participants to or the performance of this study
11. Participation in any clinical trial or use of any investigational medicinal product 1 month before screening visit

Where it's running

• Chinese University of Hong Kong
  Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Jack KC Ng, FRCP — Chinese University of Hong Kong
• Study coordinator: Jack KC Ng, FRCP
• Email: jackng@cuhk.edu.hk
• Phone: +852 37636098

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.