Treatment of Drug-resistant Adult and Pediatrc Primary Focal Segmental Glomerulosclerosis and Post -Transplant Recurrence Using the LIPOSORBER® LA-15 System
Kaneka Medical America LLC
Summary
This multicenter, prospective, single-arm clinical study will evaluate the probable benefit and safety of the LIPOSORBER® LA-15 System for the treatment of adult patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when the standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, have been unsuccessful or not well tolerated, and the patient has a GFR ≥ 45 ml/min/1.73m2, or the patient has post-renal transplant recurrence. Treatment for FSGS is considered unsuccessful if the patient is unresponsive to standard therapy (e.g., at least 8 weeks of corticosteroids) and fails to achieve complete or partial remission. A standard treatment is considered not well tolerated if the patient experiences severe side effects without providing an acceptable level of clinical benefit.
Description
This study will enroll up to 35 adult patients at 3-10 clinical sites. The duration of the treatment phase of the study will take approximately 9 weeks for a total of 12 apheresis treatments with the LIPOSORBER® LA-15 System; the treatments will be given twice weekly for 3 weeks followed by once weekly for 6 weeks. Patients will undergo follow-up at 1, 3, 6, 12, and 24 months after the final apheresis treatment. This study is conducted as a Post Approval Study imposed by Humanitarian Device Exemption (HDE) order to confirm the safety and efficacy of the LIPOSORBER® LA-15 System in the treatme…