Status:
RECRUITING
SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients
Lead Sponsor:
Odense University Hospital
Collaborating Sponsors:
Aarhus University Hospital
Copenhagen University Hospital, Denmark
Conditions:
Kidney Transplantation Recipients
Sodium-Glucose Transporter 2 Inhibitors
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ki...
Detailed Description
Background: Kidney transplantation is the best treatment for end-stage renal disease (ESRD), although the median allograft survival is only 15 years. In non-transplant patients with chronic kidney di...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT07143773
Start Date
September 1 2025
End Date
August 1 2027
Last Update
August 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 2. floor
Odense, Denmark, 5000