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

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 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

• Kidney Transplantation Recipients
• Sodium-Glucose Transporter 2 Inhibitors
• Non-Diabetic Patients
• Randomized Controlled Trial
• Placebo 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.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Copenhagen University Hospital, Denmark

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Lotte B Lange, MD · Department of Nephrology, Odense University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2027-06-01

Completion

2027-08-01

Countries

• Denmark

Study Locations