Baxter begins enrolment for Phase III trial of citrate anticoagulant and renal replacement solution combination

3rd November 2016 (Last Updated November 3rd, 2016 18:30)

US healthcare company Baxter has begun enrolment for its Phase III clinical trial of a drug that is a combination of citrate anticoagulant and renal replacement solution to treat acute kidney-injury patients receiving continuous renal replacement therapy (CRRT).

US healthcare company Baxter has begun enrolment for its Phase III clinical trial of a drug that is a combination of citrate anticoagulant and renal replacement solution to treat acute kidney-injury patients receiving continuous renal replacement therapy (CRRT).

The Phase III multi-centre, prospective, randomised, controlled clinical trial will examine the efficacy of the citrate coagulant with renal replacement solution on the extracorporeal circuit life in 160 patients admitted in intensive care unit (ICU) treated with CRRT.

The trial will be conducted through the course of next year.

The patients will be randomised to receive either CRRT with regional citrate anticoagulant (Prismocitrate 18) or CRRT with no anti-coagulant.

"One potential obstacle in delivering effective CRRT occurs when blood flow through the circuit is slowed or completely stopped by blood clots."

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.''

During CRRT, blood passes through the extracorporeal circuit to help clear waste products in the blood, returning it to a normal state. This cleaned blood is then returned to the body.

Clinicians can prescribe an anticoagulant to help reduce the likelihood of circuit clotting. When blood flow through the circuit is interrupted, patients may not receive the prescribed dose of CRRT, which may impact its effectiveness.

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

Combining two different drug solutions together may make it easier for healthcare providers to administer therapy at the bedside.