Study of Extended-Release Metformin Plus Standard Care to Reduce Podocyte Injury in Adults with Focal Segmental Glomerulosclerosis

What this Trial Is About

Researchers are investigating the use of extended-release Metformin MF alongside standard treatments to reduce podocyte injury and support podocyte survival in people with Focal Segmental Glomerulosclerosis FSGS, a kidney disease that can lead to end-stage kidney disease. FSGS involves damage to specialized kidney cells called podocytes, which are vital for kidney function. This study aims to evaluate whether Metformin can improve podocyte health compared to a placebo over six months. Participants will be randomly assigned to receive either daily oral extended-release Metformin 500 mg tablets plus standard care or daily placebo tablets plus standard care for six months. Standard care includes immune-modulating treatments like corticosteroids and blood pressure management. The study includes a triple-blind design to ensure unbiased results. Researchers will monitor the effects of Metformin on kidney cells using urine tests and kidney biopsies. During the study, participants will undergo assessments including blood and urine tests, kidney biopsies, and symptom questionnaires to evaluate kidney function, protein levels in urine, and possible side effects related to Metformin. The primary outcome measures focus on changes in urinary markers of podocyte injury over six months. Secondary outcomes will assess kidney filtration rates, proteinuria, quality of life, and safety indicators. The trial will last six months with ongoing monitoring and evaluation of kidney health and treatment safety.

AMPK-activation by Metformin in FSGS: AMP-FSGS