SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Double-blind, Placebo Controlled, National, Multicenter Trial

What this Trial Is About

Researchers are investigating the safety and effectiveness of a drug called SGLT2 inhibitor (Forxiga) in non-diabetic adults who have received kidney transplants. The study aims to find out if taking this drug daily for 18 months helps preserve kidney transplant function compared to a placebo, and to assess its safety by monitoring kidney function changes and adverse events. The trial also examines how the drug impacts urinary tract infections, post-transplant diabetes, prediabetes, and various kidney and heart-related health markers. Participants will be randomly assigned to one of two groups: one receiving a daily 10 mg tablet of SGLT2 inhibitor (Forxiga) and the other receiving a placebo tablet with no active medicine. Both treatments are given alongside standard immunosuppressive therapy for 18 months. After starting treatment, participants will be monitored closely with check-ups at one week, four weeks, and then every three months. Each visit will include urine and blood tests to evaluate kidney function and safety, while neither the participants nor the study doctors will know which treatment is given. During the trial, participants will have blood and urine samples taken at outpatient clinics, usually 1 to 7 days before scheduled follow-up calls or visits. Researchers will measure kidney function using estimated glomerular filtration rate (eGFR) starting at week 4 and then every three months up to 18 months. They will also track other health outcomes such as urinary infections, diabetes status, blood pressure, heart events, and quality of life through questionnaires. Safety monitoring includes recording adverse events and serious health issues throughout the study period.

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