The first patient has been enrolled in the multi-center, prospective, randomized, controlled clinical trial, which is anticipated to run through 2017.
About 160 ICU patients will be enrolled in the US and Canada. Participants will be randomized to receive either regional citrate anticoagulant (Prismocitrate 18) or CRRT with no anticoagulant.
The primary endpoint is the time to occurrence of selected Prismaflex System alarms/conditions for up to 120 hours post treatment initiation.
If approved, the product has the potential to be the first citrate anticoagulant cleared for use during CRRT in the US.
Baxter acute therapies medical director Farah Ali said: “One potential obstacle in delivering effective CRRT occurs when blood flow through the circuit is slowed or completely stopped by blood clots.
“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.”
Baxter has two global business units which include hospital products and renal. The hospital products business manufactures products used in the delivery of fluids and drugs to patients across the continuum of care.
The company’s renal portfolio offers a range of therapeutic options across home, in-center, and hospital settings for patients with kidney failure or kidney disease and their healthcare providers.
Image: Baxter International has started a phase 3 clinical trial of an investigational drug combining a citrate anticoagulant and renal replacement solution. Photo: courtesy of jk1991 at FreeDigitalPhotos.net.