Baxter International Inc. has started a Phase 3 clinical trial evaluating an investigational drug that combines a citrate anticoagulant and renal replacement solution to determine if it lengthens the extracorporeal circuit life in acute kidney injury patients treated with continuous renal replacement therapy (CRRT). Currently, there is no citrate anticoagulant approved for use in CRRT in the United States.
The first patient has been enrolled in the clinical trial and has received CRRT. The multi-center, prospective, randomized, controlled clinical trial, which is expected to run through 2017, will include an estimated 160 ICU patients in the United States and Canada. Patients will be randomly assigned to receive either CRRT with regional citrate anticoagulant (Prismocitrate 18) or CRRT with no anticoagulant.
“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. “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.”