LIPOSORBER® LA-15 System for Focal Segmental Glomerulosclerosis
(FSGSALLAGE Trial)
Trial Summary
What is the purpose of this trial?
This trial tests a blood-filtering device called the LIPOSORBER® LA-15 System in adults with kidney issues from FSGS who haven't had success with other treatments or have had severe side effects. The device helps by cleaning the blood to protect the kidneys.
Will I have to stop taking my current medications?
You may need to stop taking certain medications. Specifically, ACE inhibitors must be stopped at least 24 hours before each treatment, and other blood pressure medications should not be taken on the day of the procedure until after it is done.
What data supports the effectiveness of the LIPOSORBER LA-15 treatment for Focal Segmental Glomerulosclerosis?
The LIPOSORBER LA-15 treatment showed some effectiveness in patients with drug-resistant Focal Segmental Glomerulosclerosis, with partial or complete remission of symptoms in several patients over a follow-up period. Additionally, the treatment has been effective in lowering cholesterol levels in patients with familial hypercholesterolemia, indicating its potential in managing conditions related to lipid imbalances.12345
How is the LIPOSORBER® LA-15 treatment different from other treatments for focal segmental glomerulosclerosis?
The LIPOSORBER® LA-15 treatment is unique because it uses a process called apheresis, which involves filtering the blood to remove harmful substances, unlike traditional treatments that often rely on medications like steroids. This approach can be particularly beneficial for patients who do not respond well to standard drug therapies.678910
Eligibility Criteria
This trial is for adults and children with a kidney disease called primary FSGS who haven't improved on standard treatments or can't handle their side effects. Participants need to have a certain level of kidney function (GFR ≥ 45 ml/min/1.73m2) and can be post-kidney transplant patients. It's not for those over 75, under 22, with severe health issues that could affect the study, or women who are pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive extracorporeal treatment using the LIPOSORBER® LA-15 System, twice weekly for 3 weeks and then once weekly for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment at 1, 3, 6, 12, and 24 months
Treatment Details
Interventions
- LIPOSORBER® LA-15
LIPOSORBER® LA-15 is already approved in United States for the following indications:
- Nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS)
- Familial Hypercholesterolemia (FH)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kaneka Medical America LLC
Lead Sponsor