NCT05758077

Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury

A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients With Acute Kidney Injury Requiring Continuous Kidney Replacement Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 339 (estimated)
• Sponsor: SeaStar Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) when compared to CKRT alone (standard of care). This study is further intended to determine whether SCD therapy will reduce the duration of maintenance dialysis secondary to AKI. This study will enroll approximately 339 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DEVICE	Selective Cytopheretic Device	The Selective Cytopheretic Device (SCD) is comprised of tubing, connectors, and a synthetic hollow fiber membrane cartridge. The device is connected in series to a commercially available CKRT hemofilter. Blood from the CKRT circuit is diverted after the CKRT hemofilter through to the extracapillary space (ECS) of the SCD cartridge. Blood circulates through the SCD ECS and then it is returned to the patient via the venous return line of the CKRT circuit. Regional citrate anticoagulation is used for the entire CKRT and SCD blood circuit. The SCD cartridge incorporates a synthetic hollow fiber membrane with the ability to bind activated leukocytes to its extracapillary surface; and when used in a CKRT extracorporeal circuit in the presence of regional citrate anticoagulation, the SCD modulates inflammation.
OTHER	Standard of Care	Standard of care CKRT for the subject's condition, as appropriate

Timeline

• Start date: 2023-04-17
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2023-03-07
• Last updated: 2026-03-24

Locations

33 sites across 1 country: United States

Regulatory

• FDA-regulated device study