This clinical trial investigates whether 18 months of daily SGLT2i (10 mg Forxiga) preserves kidney function and evaluates safety, based on eGFR changes and adverse event occurrence in non-diabetic kidney transplant recipients.
The main questions it aims to answer are:
* Does SGLT2i versus placebo, as an add-on to standard care, preserve kidney transplant function in non-diabetic recipients? * Is SGLT2i treatment safe for non-diabetic transplant recipients when evaluating adverse events? * Does SGLT2i versus placebo affect the occurrence of urinary tract infections, post-transplant diabetes mellitus (PTDM) and prediabetes incidence, U-ACR, as well as renal and cardiovascular parameters?
Researchers will compare a daily dose of SGLT2i (10 mg Forxiga) with a placebo (a look-alike tablet with no active medicine).
Kidney transplant recipients who do not have diabetes can take part if they meet the study's requirements. Participants will be randomly assigned to receive either Forxiga or placebo once daily for 18 months. All participants will have check-ups every 3 months, which will include urine tests and blood samples. Neither the participants nor the study doctors will know which treatment they are receiving.
Obtained written informed consent
Male or female patients, age ≥ 18 years.
Non-diabetic KTR
> 6 months post-transplant
Patients treated (diet or antidiabetics) for diabetes type 1 or 2 before randomization
eGFR< 25 ml/min/1.73m2 (before randomization)
Alanine aminotransferase (ALAT) > 3 x upper normal limit
Bilirubin > 2 x upper normal limit
Odense University Hospital
Lead sponsor
Aarhus University Hospital
Collaborator
Copenhagen University Hospital, Denmark
Collaborator
Gødstrup Hospital
Collaborator