Study of Dapagliflozin 10 mg to Protect Kidney Function and Structure in Adults After Kidney Transplant at Oslo University Hospital

What this Trial Is About

Researchers are evaluating the effects of SGLT2 inhibition in patients who received a kidney transplant 6 weeks earlier at Oslo University Hospital. The study aims to determine if dapagliflozin can help preserve kidney filtration function, reduce kidney tissue scarring, and improve metabolic risk factors like obesity, glucose intolerance, and high blood pressure that could lead to graft failure. This is a randomized, placebo-controlled trial involving 330 participants. Participants are randomly assigned to receive either dapagliflozin 10 mg or a placebo once daily, starting 6 weeks after transplantation. The study lasts for 150 weeks about 3 years, with detailed assessments before treatment and at several points during follow-up. Investigations include kidney biopsies, measured and estimated glomerular filtration rate GFR, blood pressure, oral glucose tolerance tests, body composition scans DXA, and urine protein measurements. Molecular analyses of kidney tissue samples will also be conducted in a subgroup. Throughout the trial, participants will undergo repeated blood tests, blood pressure monitoring, and kidney function evaluations at multiple timepoints, including weeks 2, 8, 72, 78, and 150 after randomization. The study will monitor kidney function changes over time, kidney tissue fibrosis, metabolic changes, and safety. After the study, participants may continue treatment with SGLT2 inhibitors if deemed appropriate by their doctors, and long-term outcomes like graft loss and cardiovascular events will be tracked up to 10 years post-transplantation.

Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?