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New treatment option for Chronic Kidney Diseases
Official title Effect of Dapagliflozin on Metabolomics and Cardiac Mechanics in Chronic Kidney Disease
ClinicalTrials.gov ID: NCT05719714
What this study is testing
What is Dapagliflozin 10 MG [Farxiga]?
Dapagliflozin 10 MG [Farxiga] is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic kidney diseases.
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 goal of this study is to better understand the effects of a sodium-glucose transport protein 2 inhibitor, dapagliflozin, added on to standard of care on heart and lung function and circulating metabolites (substances created when our bodies break down food, drugs, or its own tissues) in patients with chronic kidney disease.
- 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 85
You may be able to join if
- \>18 years of age
- eGFR 25-60 ml/min/1,73m2 (eGFR = estimated glomerular filtration rate)
- On stable doses of diuretics and/or angiotensin converting enzyme inhibitor or angiotensin receptor blocker
- Evidence of subclinical heart failure with preserved ejection fraction at their pre-exercise echocardiogram (defined as meeting 3/5 of the American...
You likely can't join if
- presence or history of diabetes
- coronary revascularization within the last 6 months
- hemodynamically significant valvular disease
- significant lung disease requiring home oxygen
- angina (chest pain)
- non-revascularized myocardial ischemia
See the full eligibility criteria
- \>18 years of age
- eGFR 25-60 ml/min/1,73m2 (eGFR = estimated glomerular filtration rate)
- On stable doses of diuretics and/or angiotensin converting enzyme inhibitor or angiotensin receptor blocker
- Evidence of subclinical heart failure with preserved ejection fraction at their pre-exercise echocardiogram (defined as meeting 3/5 of the American Society of Echocardiography (ASE) criteria for diastolic dysfunction...
- presence or history of diabetes
- coronary revascularization within the last 6 months
- hemodynamically significant valvular disease
- significant lung disease requiring home oxygen
- angina (chest pain)
- non-revascularized myocardial ischemia
- systolic BP \ 180 mmHg
- pregnancy
- clinical heart failure symptoms
- history of systemic disease processes that can cause HFpEF such as amyloidosis or sarcoidosis
- any musculoskeletal or chronic condition that will interfere with completion of cardiac testing
- active cancer
- immunosuppressive therapy
- baseline or pre-exercise echocardiogram demonstrates a reduced ejection fraction \< 50%
- currently on sodium glucose cotransporter 2 inhibitor (SGLT2i) therapy
- Hypersensitivity to a SGLT2i
- Pre-existing liver disease
- ALT/AST\> 3x normal (ALT = alanine aminotransferase AST = aspartate aminotransferase)
- history of recurrent urinary tract infections (in the opinion of the investigator) or a urinary tract infection in the last 3 months
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, 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 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 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, 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.