drugset / Trial / NCT05900284
Safety and Feasibility of Metformin for Sepsis Induced AKI
Phase 2
Completed
80 enrolled
Hernando Gomez
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Acute kidney injury (AKI) is an independent risk factor for death that affects 10-15% of hospitalized patients and more than 50% of patients admitted to the intensive care unit. Sepsis is the most frequent cause of AKI, affecting 48 million people worldwide every year, and accounting for approximately 11 million of annual global deaths. Despite these figures, there are no known therapies to prevent or reverse septic AKI; hence this study aims to establish the safety and feasibility of the implementation of metformin in the treatment of AKI in patients with sepsis. This study is the first critical step to inform the design of a future, full-scale efficacy randomized clinical trial.
Timeline
- Start
- 2023-11-08
- Primary completion
- 2026-05-18
- Completion
- 2026-05-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 500 mg | Oral |
| Subject | Metformin | Small molecule | 1000 mg | Oral |