DAPARHT: DAPAgliflozin for Renal protection in Heart Transplant recipients
- Conditions
- Kidney failure, Heart transplantTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-506486-60-01
- Lead Sponsor
- Oslo University Hospital HF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 220
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, The subject is, in the opinion of the Investigator, clinically suitable for randomisation to dapagliflozin/placebo
Contraindications to study medication, Breastfeeding, Female subject who has either (1) not used at least one highly effective method of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilised or postmenopausal, Estimated GFR < 25 ml/min/m2, Type 1 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
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