Chronic kidney disease MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: Forxiga
Product Name: Forxiga
Pharmaceutical Form: Tablet
INN or Proposed INN: Dapagliflozin
CAS Number: 461432-26-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Department of Cardiology, Herlev and Gentofte hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 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: o 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 - 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
Exclusion criteria
Exclusion criteria: - 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 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in measurements of cardiac structure and function assessed by echocardiography - Change in measurements of cardiac and inflammatory biomarkers - Change in measurements of renal biomarkers - Change in measurements of metabolic biomarkers - Change in measurements of arterial stiffness assessed by applanation tonometry ;Timepoint(s) of evaluation of this end point: 6 months | — |
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark
Contacts
Public ContactKatja Vu
Cardiovascular Non-Invasive Imaging Research Laboratory
Outcome results
None listed