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 surgeryi, and AKI often requires patients to undergo dialysis. More than 200,000 CABG procedures are carried out in the US annuallyii. 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 evidenceiii 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 ouabainiv,v. This study examines whether providing DigiFab® will reduce ouabain levels and lower the risk of developing kidney damage after heart surgery.
In the trial, 250 patients who are scheduled to undergo CABG procedures at University of Maryland Medical Center and University of Maryland St Joseph Medical Center will be screened, enrolled and randomized to treatment with either DigiFab® or placebo. The study involves a follow up period after CABG surgery to evaluate renal function and the need for dialysis.