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SGL-TX-PTDM: Forxiga for Post-Transplant Diabetes Prevention in Kidney Transplant Recipients
NCT07682350Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Sep 2026
- Primary completion
- Sep 2029
- Countries
- 1
- Sponsor
- University Hospital Odense
- Drugs
- dapagliflozin
- Conditions
- post-transplant diabetes mellitus (PTDM)
01
Overview
Phase 2, randomised, double-blind trial of dapagliflozin in post-transplant diabetes mellitus (PTDM) (2 arms), sponsored by University Hospital Odense. Primary endpoint: Incidence of post-transplant diabetes mellitus at 12 months. Planned start Sep 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
SGLT2i
Forxiga 10 mg once daily + standard immunosuppressive therapy
Placebo
Placebo once daily + standard immunosuppressive therapy
03
Who it enrols
Adult non-diabetic kidney transplant recipients on Tacrolimus-based immunosuppression with eGFR >= 25 ml/min/1.73m2.
04
Endpoints
Primary
Incidence of post-transplant diabetes mellitus
Secondary
Prediabetes status
Change in kidney allograft function (eGFR)
Albumin/creatinine ratio
Change in biochemical parameters
Urinary tract infection incidence
Incidence of kidney transplant rejection
Renal composite outcome
Change in Systolic and diastolic blood pressure
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