Peritoneal Dialysis Complication study: Empagliflozin
Official title meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis
ClinicalTrials.gov ID: NCT05715814
What this study is testing
What is Empagliflozin 25 MG?
This is an investigational pill being studied to see if it helps protect remaining kidney function in people on peritoneal dialysis. It is designed to block a protein in the kidneys that reabsorbs sugar, which may help lower pressure inside the kidney filters.
Also referred to as Jardiance.
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
- This study is testing whether a new kidney drug is safe. It also looks at how the drug works in your body.
- Who it's for
- You may be able to join if you use peritoneal dialysis and still have some kidney function.
- What's involved
- You would take a new medicine called an SGLT2 inhibitor. The team will check how your body handles it.
- Time commitment
- The source text does not say how long the study lasts or what visits are needed.
- Phase 3: a large, late-stage study
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed and dated written informed consent.
- Patients aged ≥18 years on PD with RKF defined as at least 250 cc of urine output per day (assessed via 24-hour urine collection) and a minimum...
- Stable PD prescription, as determined by investigators.
- Stable dose of RAAS blockade if on a medication within this class for the last 30 days.
You likely can't join if
- Type 1 diabetes.
- Recent (in the 30 days prior to screening) acute coronary syndrome or cerebrovascular event.
- PD peritonitis within 30 days of screening.
- History of organ transplant, including pancreas, pancreatic islet cells or kidney transplant.
- Planned surgery/procedures or radiologic investigations requiring contrast during the trial.
- Pregnant, planning to become pregnant, or nursing an infant during the study period
See the full eligibility criteria
- Signed and dated written informed consent.
- Patients aged ≥18 years on PD with RKF defined as at least 250 cc of urine output per day (assessed via 24-hour urine collection) and a minimum measured GFR of 2 ml/min/1.73m2, as measured at least once in the last 3...
- Stable PD prescription, as determined by investigators.
- Stable dose of RAAS blockade if on a medication within this class for the last 30 days.
- Type 1 diabetes.
- Recent (in the 30 days prior to screening) acute coronary syndrome or cerebrovascular event.
- PD peritonitis within 30 days of screening.
- History of organ transplant, including pancreas, pancreatic islet cells or kidney transplant.
- Planned surgery/procedures or radiologic investigations requiring contrast during the trial.
- Pregnant, planning to become pregnant, or nursing an infant during the study period
- History of any DKA event
- Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, hemolytic anemia) at screening.
- Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial.
- Alcohol or drug abuse within the 3 months prior to screening that would interfere with trial participation based on Investigator's judgement.
- Use of SGLT2 inhibitor within 30 days prior to screening.
- Intake of an investigational drug in another trial within 30 days prior to screening.
- Patient not able to understand and comply with study requirements, based on Investigator's judgment.
- Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcome (e.g.
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
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, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.