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
Parallel
SGLT-2 inhibitor
DrugThe intervention in this clinical trial will be treatment with an SGLT2 inhibitor (Forxiga, 10 mg tablet once daily) compared with a matching placebo. A total of 88 non-diabetic kidney transplant recipients will be enrolled. All participants will be randomized in a 1:1 ratio to receive either Forxiga or placebo as an add-on to standard immunosuppressive therapy. This intervention differs from other studies by specifically targeting non-diabetic kidney transplant recipients, a population in which the efficacy and safety of SGLT2 inhibitors have not yet been established.
Placebo
DrugThe control intervention in this clinical trial will be a matching placebo tablet, identical in appearance to Forxiga (10 mg), administered once daily as an add-on to standard immunosuppressive therapy. A total of 88 non-diabetic kidney transplant recipients will be enrolled. All participants will be randomized in a 1:1 ratio to receive either placebo or Forxiga. This placebo intervention ensures blinding of both participants and investigators and allows a direct comparison of the safety and efficacy of SGLT2 inhibition versus no active treatment in this unique patient population.
Kidney transplant function
Chronic eGFR slope (ml/min/1.73m2)
Incidence of PTDM and prediabetes status
Evaluated by * HbA1c (mmol/mol) * Random blood glucose (mmol/L) * Continuous glucose monitoring with a Dexcom G7 pro sensor, 10 days on visit 5 (3 months post randomization)
Proteinuria
Urine albumin/creatinine ratio (U-ACR) (mg/g)
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Odense University Hospital
Lead sponsor
Aarhus University Hospital
Collaborator
Copenhagen University Hospital, Denmark
Collaborator
Gødstrup Hospital
Collaborator
