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Randomized double-blinded study to commence on DigiFab® for kidney injury related to CABG surgery

Monday, August 5, 2019

05 August 2019

BTG plc (LSE: BTG), the global healthcare company, today announced the start of a randomized double-blinded clinical study, initiated by researchers at the University of Maryland School of Medicine (UMSOM), that examines the role of DigiFab® (Digoxin Immune FAB (ovine)) in patients with an elevated risk of acute kidney injury undergoing coronary artery bypass graft (CABG) surgery.

Acute kidney injury (AKI) occurs in nearly 30 percent of patients undergoing CABG surgery, and AKI often requires patients to undergo dialysis. More than 200,000 CABG procedures are carried out in the US annually. In patients needing dialysis, the risk of death is very high. There are no known therapies that reduce the chance of developing kidney damage after heart surgery. There is evidence that patients with high levels of a substance called endogenous ouabain may have an increased risk of developing kidney damage.

The UMSOM researchers hypothesize that DigiFab® could prevent kidney injury by binding to ouabain. This study examines whether providing DigiFab® will reduce ouabain levels and lower the risk of developing kidney damage after heart surgery.

Read the full release from BTG.