SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Kidney Transplantation Recipients, Sodium-Glucose Transporter 2 Inhibitors, Non-Diabetic Patients, Randomized Controlled Trial, Placebo Control Design
In brief
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.
Key facts
- Study ID
- NCT07143773
- Run by
- Odense University Hospital
- People needed
- 88
- Starts
- 2025-09-01
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2025-08-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 2. floor — Odense, Denmark (enrolling)
Full record on ClinicalTrials.gov
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