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Tests treatment safety and results for Peritoneal Dialysis Complication
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?
Empagliflozin 25 MG is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for peritoneal dialysis complication.
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
- The primary aim of this study is to determine the safety and mechanisms of SGLT2 inhibition in individuals on peritoneal dialysis (PD) with residual kidney function (RKF).
- 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. immunocompromised patients, active malignancy...
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include Toronto, Ontario, Canada. 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.