35 Participants Needed

LIPOSORBER® LA-15 System for Focal Segmental Glomerulosclerosis

(FSGSALLAGE Trial)

Recruiting at 9 trial locations
LA
AK
Overseen ByAyaka Kitamura
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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

I have FSGS with unsuccessful standard treatments and my kidney function is still okay.
I have had a kidney transplant.

Exclusion Criteria

I do not have serious heart problems like uncontrolled irregular heartbeat or severe heart failure.
Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint or that may cause noncompliance with the study plan or confound the data analysis
You are pregnant, breastfeeding, or planning to get pregnant before the study is finished. If you have the potential to become pregnant, you should avoid getting pregnant while using the LIPOSORBER device and during the study.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive extracorporeal treatment using the LIPOSORBER® LA-15 System, twice weekly for 3 weeks and then once weekly for 6 weeks

9 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment at 1, 3, 6, 12, and 24 months

24 months
5 visits (in-person)

Treatment Details

Interventions

  • LIPOSORBER® LA-15
Trial OverviewThe LIPOSORBER® LA-15 System is being tested in this study. It's designed for people whose focal segmental glomerulosclerosis hasn't responded to usual treatments like steroids or calcineurin inhibitors, or if these treatments caused severe side effects.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: LIPOSORBER® LA-15 SystemExperimental Treatment1 Intervention
All study patients who meet the study eligibility criteria will undergo the extracorporeal treatment using LIPOSORBER® LA-15 System. The participants are to be treated with the system twice weekly for the 3weeks and then once weekly for the following 6 weeks.

LIPOSORBER® LA-15 is already approved in United States for the following indications:

🇺🇸
Approved in United States as LIPOSORBER LA-15 System for:
  • 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

Trials
13
Recruited
720+

Findings from Research

In a multicenter study involving 17 patients with drug-resistant primary FSGS, lipoprotein apheresis using the Liposorber® LA-15 system showed promising results, with partial or complete remission of nephrotic syndrome observed in 66.7% of patients at the 6-month follow-up.
All patients demonstrated improved or stable kidney function (eGFR) over the follow-up period, indicating that lipoprotein apheresis may enhance the effectiveness of standard treatments for resistant cases of primary FSGS.
Dextran-Sulfate Plasma Adsorption Lipoprotein Apheresis in Drug Resistant Primary Focal Segmental Glomerulosclerosis Patients: Results From a Prospective, Multicenter, Single-Arm Intervention Study.Raina, R., Krishnappa, V., Sanchez-Kazi, C., et al.[2020]
In a multicenter trial involving 120 patients with severe hypercholesterolemia, LDL apheresis using the Liposorber LA-15 system resulted in significant reductions in total cholesterol (TC) by 52.6% and LDL-cholesterol (LDL-C) by 63.1% during treatment, demonstrating its efficacy for patients unresponsive to diet and maximum drug therapy.
The treatment was generally well tolerated, with adverse events primarily related to hypotension occurring in only 1% of treatments, indicating that LDL apheresis is a safe option for managing severe hypercholesterolemia, although caution is advised for patients on ACE inhibitors due to potential severe reactions.
Low-density lipoprotein apheresis for prevention and regression of atherosclerosis: clinical results.Bambauer, R., Olbricht, CJ., Schoeppe, E.[2019]
Liposorber effectively purifies plasma by selectively adsorbing low-density lipoproteins, making it useful for treating conditions like familial hypercholesterolemia, peripheral arterial disease, and focal segmental glomerulosclerosis.
Selesorb targets and removes specific antibodies and immune complexes, providing a treatment option for patients with systemic lupus erythematosus, especially those who do not respond to standard medications.
Blood purification therapies using dextran sulfate cellulose columns Liposorber and Selesorb.Asahi, T., Yamamoto, T., Kutsuki, H.[2022]

References

Dextran-Sulfate Plasma Adsorption Lipoprotein Apheresis in Drug Resistant Primary Focal Segmental Glomerulosclerosis Patients: Results From a Prospective, Multicenter, Single-Arm Intervention Study. [2020]
Low-density lipoprotein apheresis for prevention and regression of atherosclerosis: clinical results. [2019]
Blood purification therapies using dextran sulfate cellulose columns Liposorber and Selesorb. [2022]
Adsorption of lipoprotein containing apolipoprotein-B through plasma separation for treatment of familial hypercholesterolemia. [2017]
Low-density lipoprotein apheresis using the Liposorber dextran sulfate cellulose system for patients with hypercholesterolemia refractory to medical therapy. [2005]
Proteinuria and focal segmental glomerulosclerosis in severely obese adolescents. [2022]
Aggressive treatment of severe idiopathic focal segmental glomerulosclerosis. [2022]
Chronic kidney disease predictors in obese adolescents. [2022]
Treatment and prognosis of primary focal segmental glomerulosclerosis. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
Effects of steroids in focal segmental glomerulosclerosis in a predominantly African-American population. [2022]