Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients With Chronic Kidney Disease

• Status: Not yet recruiting
• Trial end date: 2025-04-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tor Biering-Sørensen
• Treatments: Dapagliflozin

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