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New treatment option for End Stage Renal Disease on Dialysis
Official title Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
ClinicalTrials.gov ID: NCT05671991
What this study is testing
What is Empagliflozin 10 MG?
Empagliflozin 10 MG is an investigational medicine, given as an once-daily, being studied as a potential treatment for end stage renal disease on dialysis.
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 main purpose of the study is to determine if empagliflozin can reduce peritoneal glucose absorption in patients with end stage renal diease (ESRD) on peritoneal dialysis. This is a randomized, placebo controlled, acute crossover study of empagliflozin in an anticipated 30 chronic PD patients, with an 8 week "pre post" open label extension in all 30 patients where they will receive empagliflozin daily.
- Phase 4: studies an already-approved treatment
- Time commitment: about 9 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, 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 and older
You may be able to join if
- Patients actively undergoing PD with a reliably functioning PD catheter
- Stable peritoneal dialysis prescription
- PD vintage \> 3 months
- Age \>18 years of age
You likely can't join if
- History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent...
- Use of an SGLT2 inhibitor within the prior 30 days
- 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
- Anemia with hemoglobin \<8g/dL
- Inability to give written informed consent or follow study protocol
- Contraindication to receiving loop diuretics
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
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 9 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 New Haven, Connecticut, United States. 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.