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New treatment option for Chronic Kidney Disease Requiring Hemodialysis
Official title Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study
ClinicalTrials.gov ID: NCT06929169
What this study is testing
What is iSGLT2?
iSGLT2 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic kidney disease requiring hemodialysis.
Also referred to as SGLT2 inhibitor.
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
- Patients with end-stage kidney disease (ESKD) on hemodialysis face an unacceptably high rate of cardiovascular complications, including heart failure, arrhythmias, and sudden cardiac death. Many of these outcomes are driven by diastolic dysfunction and cardiac fibrosis-conditions that are not adequately addressed by current therapies.
- 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 70
You may be able to join if
- Age ≥18 and ≤70 years
- Diagnosed with end-stage renal disease
- Undergoing online hemodiafiltration for at least 3 months
- Able to provide written informed consent
You likely can't join if
- Current immunosuppressive therapy
- Contraindication to cardiac MRI
- Known hypersensitivity or intolerance to SGLT2 inhibitors
- Participation in another treatment clinical trial
- History of diabetic ketoacidosis
- Active substance abuse
See the full eligibility criteria
- Age ≥18 and ≤70 years
- Diagnosed with end-stage renal disease
- Undergoing online hemodiafiltration for at least 3 months
- Able to provide written informed consent
- Current immunosuppressive therapy
- Contraindication to cardiac MRI
- Known hypersensitivity or intolerance to SGLT2 inhibitors
- Participation in another treatment clinical trial
- History of diabetic ketoacidosis
- Active substance abuse
- Diagnosis of type 1 diabetes mellitus
- History of kidney transplantation
- Acute coronary event within 30 days before enrollment
- Current or recent treatment with an SGLT2 inhibitor
The study team makes the final eligibility decision.
Where it's taking place
- Buenos Aires, Buenos Aires, Argentina
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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buenos Aires, Buenos Aires, Argentina. 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.