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SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients

RecruitingPhase 4Ages 18 Years - anyAllOdense University Hospital
NCT07143773 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 the

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📋 Eligibility rules (as published)
Inclusion Criteria: * Obtained written informed consent * Male or female patients, age ≥ 18 years. * Non-diabetic KTR * \> 6 months post-transplant * eGFR\> 25 ml/min/1.73m2 within the last 3 months pre randomization * Immunosuppressive must include Tacrolimus * Negative plasma hCG in fertile women\*, and acceptance of the use of contraception during the course of the study. Exclusion Criteria: * 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 * Pregnancy * Breastfeeding * Known allergy towards SGLT2i or the content substance * Known intestinal bowel disease
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What it tests

  • SGLT-2 inhibitor
  • Placebo
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Where

1 site
Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 2. floor
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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