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New treatment option for Chronic Kidney Diseases
Official title Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with CKD
ClinicalTrials.gov ID: NCT05359263
What this study is testing
What is Dapagliflozin 10 mg?
Dapagliflozin 10 mg 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 purpose of this study is to investigate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 informed consent
- ≥ 18 years of age
- Chronic kidney disease (CKD), defined as evidence of decreased eGFR (eGFR ≥20 and \<60 mL/minute per 1.73 m2) or between eGFR ≥60 and \<90 mL/minute...
- Stable treatment with clinically appropriate doses of ACEi/ARB among CKD patients with proteinuria and uptitrated to maximal recommended or tolerated...
- For patients with type 2 diabetes: Stable antihyperglycemic treatment \> 30 days before screening
You likely can't join if
- Type 1 diabetes
- For patients with type 2 diabetes: History of diabetic ketoacidosis
- Patients undergoing dialysis
- History of organ transplant
- Treatment with SGLT2 inhibitor within 8 weeks prior to enrolment
- Known allergy or hypersensitivity to SGLT2 inhibitors or Placebo ingredients
See the full eligibility criteria
- Signed informed consent
- ≥ 18 years of age
- Chronic kidney disease (CKD), defined as evidence of decreased eGFR (eGFR ≥20 and \<60 mL/minute per 1.73 m2) or between eGFR ≥60 and \<90 mL/minute per 1.73 m2 with urinary albumin:creatinine ratio ≥200 mg/g or...
- Stable treatment with clinically appropriate doses of ACEi/ARB among CKD patients with proteinuria and uptitrated to maximal recommended or tolerated dose for at least 4 weeks before randomization, if not medically...
- For patients with type 2 diabetes: Stable antihyperglycemic treatment \> 30 days before screening
- Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of...
- Ability to understand and read Danish
- Type 1 diabetes
- For patients with type 2 diabetes: History of diabetic ketoacidosis
- Patients undergoing dialysis
- History of organ transplant
- Treatment with SGLT2 inhibitor within 8 weeks prior to enrolment
- Known allergy or hypersensitivity to SGLT2 inhibitors or Placebo ingredients
- Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks of enrolment
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment
- Any condition outside the renal and cardiovascular study area with a life expectancy of \<2 years based on investigator's clinical judgement
- Hepatic impairment (aspartate transaminase or alanine transaminase \>3 times the upper limit of normal [ULN] or total bilirubin \>2 times the ULN at the time of enrolment)
- Known blood-borne diseases, such as Hepatitis A, B, C, D, and E, and Human immunodeficiency virus (HIV) types 1 and 2, Ebola, Lassa fever virus.
- Female patients who are pregnant, lactating, or are considering becoming pregnant during the study or for 6 months after study completion
- Participation in another clinical study with an investigational product within the last month prior to enrolment
- Inability to understand or comply with the investigational product, procedures, and/or follow-up or any conditions that may prevent the participant to complete the study
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. 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.