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NCT05359263 | Recruiting | Chronic Kidney Diseases

Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients With CKD
Sponsor:

Tor Biering-Sørensen

Information provided by (Responsible Party):

Tor Biering-Sørensen

Brief Summary:

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.

Condition or disease

Chronic Kidney Diseases

Intervention/treatment

Dapagliflozin 10 mg

Placebo

Phase

Phase 2

Detailed Description:

The study is a 6-month, investigator-initiated, randomized, double-blind, placebo-controlled clinical trial to evaluate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease. The study population will consist of approximately 222 adults with chronic kidney disease - defined as a glomerular filtration rate (GFR) of 20-60 mL/min/1.73m2, in treatment with maximally tolerated ACEi or ARB. Patients will be randomized to either 10 mg dapagliflozin or placebo. Patients will be assessed by measurement of echocardiography, pulse wave velocity, blood samples, urine samples, quality of life, depressive symptoms, and cognitive function at baseline and after 6 months of treatment.}}

Study Type : Interventional
Estimated Enrollment : 222 participants
Masking : Triple
Primary Purpose : Treatment
Official Title : A 6-Month, Randomized, Double-Blind Study to Evaluate the Effect of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients With Chronic Kidney Disease
Actual Study Start Date : June 8, 2022
Estimated Primary Completion Date : April 15, 2025
Estimated Study Completion Date : April 15, 2025
Arm Intervention/treatment

Experimental: Dapagliflozin 10 mg once daily

Drug: Dapagliflozin 10 mg

Placebo Comparator: Placebo once daily

Drug: Placebo
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Signed informed consent
  • ≥ 18 years of age
  • Chronic Kidney Disease (CKD), defined as evidence of decreased eGFR (eGFR >20 and <60 mL/min/1.73 m2) at least 3 months before and at the time of screening
  • 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 contraindicated
  • 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 contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device
    • Ability to understand and read Danish
    Exclusion Criteria
    • Type 1 diabetes
    • For patients with type 2 diabetes
      • History of diabetic ketoacidosis
      • Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
      • 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
Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients With CKD

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Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients With CKD

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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

Denmark,

Gentofte Hospital

Copenhagen, Denmark, 2900