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

PHASE4RecruitingINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

June 1, 2027

Study Completion Date

August 1, 2027

Conditions
Kidney Transplantation RecipientsSodium-Glucose Transporter 2 InhibitorsNon-Diabetic PatientsRandomized Controlled TrialPlacebo Control Design
Interventions
DRUG

SGLT-2 inhibitor

The intervention in this clinical trial will be treatment with an SGLT2 inhibitor (Forxiga, 10 mg tablet once daily) compared with a matching placebo. A total of 88 non-diabetic kidney transplant recipients will be enrolled. All participants will be randomized in a 1:1 ratio to receive either Forxiga or placebo as an add-on to standard immunosuppressive therapy. This intervention differs from other studies by specifically targeting non-diabetic kidney transplant recipients, a population in which the efficacy and safety of SGLT2 inhibitors have not yet been established.

DRUG

Placebo

The control intervention in this clinical trial will be a matching placebo tablet, identical in appearance to Forxiga (10 mg), administered once daily as an add-on to standard immunosuppressive therapy. A total of 88 non-diabetic kidney transplant recipients will be enrolled. All participants will be randomized in a 1:1 ratio to receive either placebo or Forxiga. This placebo intervention ensures blinding of both participants and investigators and allows a direct comparison of the safety and efficacy of SGLT2 inhibition versus no active treatment in this unique patient population.

Trial Locations (1)

5000

RECRUITING

Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 2. floor, Odense

All Listed Sponsors
collaborator

Aarhus University Hospital

OTHER

collaborator

Copenhagen University Hospital, Denmark

OTHER

collaborator

Gødstrup Hospital

OTHER

lead

Odense University Hospital

OTHER

NCT07143773 - SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients | Biotech Hunter | Biotech Hunter