Actively Recruiting
SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients
Led by Odense University Hospital · Updated on 2025-08-27
88
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Male or female patients aged 18 years or older
- Non-diabetic kidney transplant recipients
- More than 6 months after kidney transplant
- eGFR greater than 25 ml/min/1.73m2 within 3 months before randomization
- Immunosuppressive treatment includes Tacrolimus
- Negative plasma hCG test in fertile women and agreement to use contraception during the study
You will not qualify if you...
- Treated for type 1 or 2 diabetes before randomization
- eGFR less than 25 ml/min/1.73m2 before randomization
- Alanine aminotransferase (ALAT) levels higher than 3 times the upper normal limit
- Bilirubin levels higher than 2 times the upper normal limit
- Pregnant or breastfeeding
- Known allergy to SGLT2 inhibitors or their components
- Known intestinal bowel disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 2. floor
Odense, Denmark, 5000
Actively Recruiting
Research Team
L
Lotte B Lange, MD
CONTACT
L
Lotte B Lange, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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