Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with CKD (DECODE-CKD)

Tor Biering-Sørensen

Status and phase

Enrolling

Phase 2

Conditions

Chronic Kidney Diseases

Treatments

Drug: Dapagliflozin 10 mg

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05359263

DECODE-CKD

Details and patient eligibility

About

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.

Full 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.

Enrollment

222 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion 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 protein:creatinine ratio ≥300 mg/g
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

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