Phase 3 Trial Launched for Citrate Anticoagulant

Baxter has begun a phase 3 clinical trial for an investigational drug that combines a citrate anticoagulant and a renal replacement solution. The goal is to determine if, and to what extent, it lengthens the extracorporeal circuit life in acute kidney patients who are treated with continuous renal replacement therapy (CRRT).

If approved, the product will provide a standardized formulation of renal replacement fluid combined with a citrate anticoagulant.

The trial will run through 2017, and it will include 160 ICU patients from the United States and Canada. They will be randomly selected to receive either CRRT with regional citrate anticoagulant (Prismocitrate 18) or CRRT with no anticoagulant. The first patient has already been enrolled in the trial and has received CRRT.

“One potential obstacle in delivering effective CRRT occurs when blood flow through the circuit is slowed or completely stopped by blood clots,'' said Farah Ali, MD, medical director for Acute therapies at Baxter, in a press release. ''Extending the life of the extracorporeal circuit can help patients with acute kidney injury remain on renal replacement therapy as prescribed, while reducing potential complications that can occur when the blood circuit needs to be replaced.”

During CRRT, blood passes through the extracorporeal circuit to clear waste products in the body. An anticoagulant is typically prescribed to patients to reduce the chances of circuit clotting.