Forxiga (SGLT2 inhibitor) to preserve kidney allograft function in non-diabetic transplant recipients
SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Double-blind, Placebo Controlled, National, Multicenter Trial
This trial will test whether taking daily Forxiga (10 mg) for 18 months helps preserve kidney transplant function and is safe for adults without diabetes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense) |
| Trial ID | NCT07143773 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) who are non-diabetic kidney transplant recipients, more than 6 months post-transplant, with eGFR >25 ml/min/1.73m2 and receiving tacrolimus-based immunosuppression are ideal candidates.
Not a fit: Patients with pre-existing diabetes, eGFR <25 ml/min/1.73m2, significant liver enzyme elevations, pregnancy or breastfeeding, known SGLT2i allergy, or inflammatory bowel disease are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, daily SGLT2 inhibition could slow eGFR decline and extend the functional life of kidney transplants while maintaining an acceptable safety profile.
How similar studies have performed: SGLT2 inhibitors have demonstrated kidney-protective effects in non-transplant chronic kidney disease, but their safety and efficacy specifically in kidney transplant recipients remain unproven in large randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Odense
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.