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New treatment option for End Stage Renal Disease on Dialysis
Official title Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
ClinicalTrials.gov ID: NCT06483074
What this study is testing
What is Empagliflozin 10 MG?
Empagliflozin 10 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for end stage renal disease on dialysis.
Also referred to as Jardiance 10mg daily.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- Patients with history of hemodialysis (≥ 3 months) or renal transplant
- Life expectancy \<6 months
- Prior use of any type of SGLT2 inhibitors within 1 month before screening visit
- Poorly controlled diabetes with HBA1c \>11%
- Type 1 diabetes
- History of any active malignancy within 5 years (except curatively resected basal cell or squamous cell skin cancers)
See the full eligibility criteria
- 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
- Patients with history of hemodialysis (≥ 3 months) or renal transplant
- Life expectancy \<6 months
- Prior use of any type of SGLT2 inhibitors within 1 month before screening visit
- Poorly controlled diabetes with HBA1c \>11%
- Type 1 diabetes
- History of any active malignancy within 5 years (except curatively resected basal cell or squamous cell skin cancers)
- Peritonitis within 4 weeks
- Ketoacidosis within 5 years
- Known hypersensitivity to empagliflozin or other SGLT2 inhibitors
- 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
- Participation in any clinical trial or use of any investigational medicinal product 1 month before screening visit
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.