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

ConditionsKidney Transplant Recipient Sodium Glucose Co-Transporter 2 Inhibitors Non-Diabetic Patients Randomized Controlled Trial (RCT)Placebo Control Design Post Transplant Diabetes Mellitus

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

SGLT2i
Drug
The 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 184 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
Drug
The 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 184 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.

Treatment groups

184 Participants

are divided into 2 treatment groups

Group A: SGLT2iActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of post-transplant diabetes mellitus (PTDM)

Domain: Post-transplant diabetes mellitus Specific measurement: Diagnosis of PTDM according to the American Diabetes Association (ADA) diagnostic criteria. Specific metric: Number of participants with PTDM Method of aggregation: Proportion of participants with PTDM in each treatment group (dapagliflozin versus placebo) Time point: 3, 6 and 12 months after randomization

Time frame