heart transplant recipients in follow-up
Conditions
Interventions
Trade Name: Forxiga 10 mg (Dapagliflozin)
Product Name: Forxiga 10 mg (Dapagliflozin)
Product Code: 0310-6205-30
Pharmaceutical Form: Buccal tablet
Pharmaceutical form of the placebo: Coated tablet
Ro
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be screened for eligibility during routine follow-up more than 1 year after heart transplant. All the following conditions must apply prior to administering the investigational medicinal product: Heart transplant recipient for = 1 year. Age = 18 years. Informed consent obtained and documented according to Good Clinical Practice (GCP), and national/regional regulations. Estimated glomerular filtration rate = 25 ml/min/1.73 m2 as assessed by the MDRD formula. 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 430 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: Contraindications to study medication. Estimated GFR < 25 ml/min/m2 Type I diabetes Severe liver failure (Child-Pugh’s score C) Life expectancy reduced to < 2 years as judged by the investigator Unresolved malignant disease Failure to obtain written informed consent SGL2 inhibitor treatment over the four weeks prior to randomisation Pregnancy Breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main goal of this study is to evaluate the effect of oral dapagliflozin on renal function in cardiac allograft recipients. ;Secondary Objective: Secondary objectives are to assess the impact of treatment on: i) weight, ii) proteinuria in the subset of patients with an albumin / creatinine ratio in the urine > 30, and iii) blood levels of glycated haemoglobin (HbA1c) in patients with diabetes mellitus, as well as iv) safety. ;Primary end point(s): The primary endpoint will be the slope of the eGFR from 2 weeks to end-of-treatment (12 months), calculated as the difference in eGFR from two weeks to 12 months after start of the intervention. The eGFR is calculated from serum creatinine using the Modification of Diet in Renal Disease (MDRD) formula.;Timepoint(s) of evaluation of this end point: From 2 weeks to end-of-treatment (12 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Baseline-adjusted body weight The change in the albumin / creatinine ratio in the urine from baseline to end-of-treatment in patients with a baseline ratio > 30 mg/g at baseline The change in the blood level of glycated haemoglobin (HbA1c) in patients with diabetes mellitus ;Timepoint(s) of evaluation of this end point: From 2 weeks to end-of-treatment (12 months) | — |
Countries
Netherlands, Norway
Contacts
Public ContactDepartment of Cardiology
Oslo University Hospital
Outcome results
None listed