LIPOSORBER® LA-15 for Drug-Resistant FSGS
This study is testing the LIPOSORBER® LA-15 system for adults and children (up to 75 years old) with primary Focal Segmental Glomerulosclerosis (FSGS), a kidney disease. This treatment is for those whose standard therapies (like corticosteroids or calcineurin inhibitors) haven't worked or caused too many side effects, and whose kidney function (GFR) is still good (45 ml/min/1.73 m2 or higher), or for those who have FSGS recurrence after a kidney transplant. The goal is to see if LIPOSORBER® LA-15 can safely help reduce the symptoms of nephrotic syndrome (a group of symptoms including protein in the urine) one month after the final treatment. The study plans to enroll up to 35 participants, but its current status is unclear.
- Study design
- This is a single-arm study, meaning all participants will receive the LIPOSORBER® LA-15 treatment. It plans to enroll up to 35 adult patients.
- What's involved
- You would receive 12 apheresis treatments with the LIPOSORBER® LA-15 system over approximately 9 weeks. Treatments are given twice weekly for 3 weeks, then once weekly for 6 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would have follow-up visits at 1, 3, 6, 12, and 24 months after your last treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System
At a glance
Conditions
Where it's being run
10 sites across 8 statesWho to contact
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What this trial measures
- Evaluate the safety and probable benefit of the LIPOSORBER® LA-15 System in relieving nephrotic syndrome associated with primary FSGS at 1 month after the final apheresis treatment. partial remission at 1 month after the final apheresis treatment.1 month after the final Apheresis treatment.
The primary probable benefit endpoint will be assessed by calculating the percent reduction in Up/c values at screening and at 1 month after the final apheresis.