Forxiga (SGLT2 inhibitor) to preserve kidney allograft function in non-diabetic transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 4 trial will give adult non-diabetic kidney transplant recipients either daily 10 mg Forxiga (an SGLT2 inhibitor) or a matching placebo for 18 months as an add-on to standard care. The primary outcome is change in estimated glomerular filtration rate (eGFR) with safety monitored through adverse event reporting. Secondary outcomes include urinary tract infection rates, new-onset post-transplant diabetes or prediabetes, urine albumin-to-creatinine ratio (U-ACR), and selected renal and cardiovascular parameters. Eligible participants are at least 6 months post-transplant, have eGFR >25 ml/min/1.73 m2, and are on tacrolimus-based immunosuppression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

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

Study contacts

• Principal investigator: Lotte B Lange, MD — Department of Nephrology, Odense University Hospital
• Study coordinator: Lotte B Lange, MD
• Email: lotte.borg.lange@rsyd.dk
• Phone: +45 40863392

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.