SGLT2i Effect on PTDM Development and Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Doubleblind, Placebo Controlled, National Multicenter Trial

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

About this trial

The goal of this clinical trial is to find out whether 12 months of treatment with the SGLT2 inhibitor Forxiga® (dapagliflozin 10 mg once daily), compared with placebo, can reduce the risk of developing post-transplant diabetes in kidney transplant recipients who do not have diabetes at the time of transplantation.

The main questions it aims to answer are:

* Does Forxiga reduce the risk of developing post-transplant diabetes and prediabetes compared with placebo? * Does Forxiga help preserve the function of the transplanted kidney compared with placebo? * Is Forxiga safe for kidney transplant recipients who do not have diabetes? * Does Forxiga affect the occurrence of urinary tract infections, the amount of protein in the urine, and other kidney- and heart-related health measures compared with placebo?

Researchers will compare Forxiga with a placebo (a look-alike tablet containing no active medicine) to see whether it can reduce the risk of post-transplant diabetes while maintaining kidney function and remaining safe to use.

Adults who have recently received a kidney transplant and do not have diabetes may take part if they meet the study requirements.

Participants will be randomly assigned to receive either Forxiga or placebo once daily for 12 months. They will attend study visits 3, 6, and 12 months after joining the study. These visits will include health checks, blood tests, and urine tests. Neither the participants nor the study doctors will know which treatment each participant is receiving.

Eligibility criteria

Qualifiers

Obtained written informed consent

Male or female patients, age ≥ 18 years.

Non-diabetic KTR

Immunosuppressive must include Tacrolimus

Disqualifiers

Patients who is 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

Trial design

Treatments tested in this trial

  • SGLT2i
  • Placebo

Treatment groups

184 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Odense University Hospital

Lead sponsor

Aarhus University Hospital

Collaborator

Copenhagen University Hospital, Denmark

Collaborator