Regional citrate anticoagulation has been standard practice in intensive care units across Europe and Asia-Pacific for years, yet U.S. critical care teams treating acute kidney injury had no FDA-cleared system designed specifically to deliver it on-label, until October 19. Fresenius Medical Care received FDA clearance for the multiFiltratePRO System alongside approval of two dedicated solutions, Cienby (sodium citrate) and Calrezdy (calcium chloride), making it the first continuous kidney replacement therapy system and solutions package cleared in the United States for on-label regional citrate anticoagulation using the Ci-Ca Protocol during CVVHD and CVVHDF.
The clinical case for the approach comes down to filter longevity. A multicenter randomized controlled trial found that citrate anticoagulation extended mean filter life to 47 hours compared with 27 hours for systemic heparin, though the trial was underpowered to draw conclusions on mortality. Longer filter life matters in the ICU because every circuit clot forces a treatment interruption for a patient who is already critically ill. The multiFiltratePRO addresses the operational side of that problem directly: its integrated citrate and calcium pumps automatically adjust infusion rates as blood and effluent flow change, removing the separate external pumps that ICU teams have historically had to manage alongside the CKRT machine itself.
Cienby carries meaningful safety requirements that hospitals will need to build into their protocols. Because citrate chelates calcium in the extracorporeal circuit, Cienby causes hypocalcemia by design, and severe hypocalcemia can produce arrhythmia, cardiac arrest, or seizure. Calrezdy replaces that calcium in the post-filter bloodline, but clinicians must also monitor for hypercalcemia, hypernatremia from citrate’s sodium load, and hypomagnesemia during prolonged therapy. Patients with severely impaired citrate metabolism are contraindicated entirely. These are not new clinical challenges for centers already using citrate off-label, but the approved labeling now gives teams a defined protocol framework rather than institution-by-institution adaptations.
The U.S. rollout starts as a controlled launch before moving to full availability, with the system on display at ASN Kidney Week 2026 in Denver at Booth 571. The metric worth watching is how quickly U.S. hospitals update their anticoagulation protocols to move from heparin or off-label citrate use toward the now-labeled Ci-Ca approach, since adoption speed will determine whether the clinical filter-life advantage translates into measurable outcomes data in the American ICU population.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
