Effects of Dapagliflozin on CarDiac StructurE and Function in Patients with Chronic Kidney Disease (DECODE-CKD)
- Conditions
- Chronic kidney diseaseMedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2021-000995-13-DK
- Lead Sponsor
- Department of Cardiology, Herlev and Gentofte hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 260
-Signed informed consent
-= 18 years of age
For those not undergoing dialysis
-Chronic Kidney Disease (CKD), defined as evidence of decreased eGFR (eGFR >=20 and <60 mL/min/1.73 m2) or evidence of albuminuria present for > 3 months if eGFR >60 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:
oStable 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
-For those undergoing hemodialysis:
- Initation of hemodialysis within 1 year of the randomization visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 111
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 111
-Type 1 diabetes
For patients with type 2 diabetes:
-History of diabetic ketoacidosis
-History of organ transplant
-Treatment with SGLT2 inhibitor within 8 weeks (not undergoing dialysis) or 4 weeks (undergoing dialysis) 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
For non-dialysis participants
-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)
For dialysis participants
- Known hepatic impairment documented in the participants electronic health record
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to investigate whether dapagliflozin reduces LV mass in patients with chronic kidney disease compared to placebo. ;Secondary Objective: The secondary objective is to identify cardiovascular and renal biomarkers by which potential effects of dapagliflozin among patients with CKD can be attributed to. These include cardiac biomarkers, function and hemodynamics, metabolic, and renal parameters. Additional exploratory endpoints include measurement of depressive symptoms, quality of life, and cognitive impairment.;Primary end point(s): -Change in LV mass index assessed by echocardiography;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Change in measurements of cardiac structure and function assessed by echocardiography<br>-Change in measurements of cardiac and inflammatory biomarkers<br>-Change in measurements of renal biomarkers<br>-Change in measurements of metabolic biomarkers<br>-Change in measurements of arterial stiffness assessed by applanation tonometry<br>;Timepoint(s) of evaluation of this end point: 6 months