Renal protection in Heart Transplant
- Conditions
- heart transplant recipients in follow-upTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2021-003175-34-NO
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 430
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method