LIPOSORBER® LA-15 System for Focal Segmental Glomerulosclerosis
(FSGSALLAGE Trial)
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kaneka Medical America LLC
Must not be taking: Ace inhibitors, Arbs, Vitamin K antagonists
Disqualifiers: Pregnancy, Cardiac impairments, Infections, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345How 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.
678910Eligibility 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.
+12 more
Trial 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)
Participant Groups
The 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.
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
Research Locations NearbySelect from list below to view details:
Loma Linda University HospitalLoma Linda, CA
Akron Children's HospitalAkron, OH
Weill Cornell Medicine / NewYork-PresbyterianNew York, NY
Nemours/Alfred I DuPont Hospital for ChildrenWilmington, DE
More Trial Locations
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Who Is Running the Clinical Trial?
Kaneka Medical America LLCLead Sponsor
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]Background: Focal segmental glomerulosclerosis (FSGS) causes end stage renal disease (ESRD) in significant proportion of patients worldwide. Primary FSGS carries poor prognosis and management of FSGS patients, refractory to standard treatments or resistant to steroids, remains a major challenge. Lipoprotein apheresis is a therapeutic approach for drug resistant primary FSGS and post-renal transplant primary FSGS recurrence. Objectives: To examine the safety and probable benefit at 1, 3, 6, 12, and 24-months following completion of apheresis treatment using Liposorber® LA-15 system in patients with nephrotic syndrome (NS), due to refractory primary FSGS or primary FSGS associated NS, in post renal transplant children. Material and Methods: Prospective, multicenter, single-arm intervention study using Liposorber® LA-15 system. Patients ≤21 years old with drug resistant or drug intolerant NS secondary to primary FSGS with glomerular filtration rate (GFR) ≥60 ml/min/1.73 m2 or post renal transplant patients ≤21 years old with primary FSGS associated NS were included in the study. Each patient had 12 dextran-sulfate plasma adsorption lipoprotein apheresis sessions over a period of 9 weeks. All patients were followed up at 1, 3, 6, 12, and 24-months following completion of treatment. Results: Of 17 patients enrolled, six were excluded from the outcome analysis (protocol deviations). Of the remaining 11 patients, all but one have completed apheresis treatments. Three patients were lost to follow-up immediately after completion of apheresis and excluded from outcome analysis. At one-month follow-up, 1 of 7 patients (14.3%) attained partial remission of NS while 2 of 4 subjects (50%) and 2 of 3 subjects (66.7%) had partial/complete remission at 3- and 6-months follow-up, respectively. One of two patients followed up for 12 months had complete remission and one patient had partial remission of NS after 24 months. Improved or stable eGFR was noted in all patients over the follow-up period. Conclusion: The results of our multicenter study showed improvement in the response rates to steroid or immunosuppressive therapy and induced complete or partial remission of proteinuria in some of the patients with drug resistant primary FSGS. The main limitation of our study is the small number of subjects and high dropout rate.
Low-density lipoprotein apheresis for prevention and regression of atherosclerosis: clinical results. [2019]Hypercholesterolemia can be adequately controlled by appropriate diet and maximum lipid lowering drug therapy in most patients. Nevertheless, there exists a group of patients, including those with familial hypercholesterolemia (FH), who remain at high risk for the development or progression of premature coronary heart disease (CHD). For these patients additional measures such as surgery and low-density lipoprotein (LDL) apheresis have to be considered. The objective of this multicenter trial, which included 30 clinical centers (28 in Germany and one each in Scotland and Luxembourg), was to determine if repeated LDL apheresis using the Liposorber LA-15 system (Kaneka Corporation, Osaka, Japan) could lead to an additional acute and time averaged lowering of total cholesterol (TC) and LDL-cholesterol (LDL-C) in severely hypercholesterolemic patients whose cholesterol levels could not be controlled by appropriate diet and maximum drug therapy. A total of 6,798 treatments were performed on 120 patients, including 8 with homozygous FH, 75 with heterozygous FH, and 37 with unclassified FH or other hyperlipidemias from 1988 through 1994. The mean TC and mean LDL-C levels at baseline were 410.0 mg/dl and 333.9 mg/dl, respectively. LDL apheresis was performed once a week or at least once every 2 weeks in all patients. During treatment with the Liposorber system the mean acute percentage reduction was 52.6% for TC and 63.1% for LDL-C. Very low density lipoprotein cholesterol (VLDL-C) and triglycerides (TG) were also substantially reduced to 60.6% and 47.5%, respectively. Fibrinogen, a potential risk factor for CHD, was reduced by 26.2%. In contrast, the mean acute reduction of high density lipoprotein (HDL) was only 3.4%. During the course of the treatment, the time averaged levels of TC and LDL-C were reduced by approximately 39% and 50%, respectively, compared to baseline levels. The adverse events (AEs) were those generally associated with extracorporeal treatments. The most common AE was hypotension, with 69 episodes corresponding to 1% of all treatments reported in 44 of the 120 patients treated. All other kinds of AEs occurred in less than 0.2% of the treatments. The treatment with the Liposorber LA-15 system was overall well tolerated. It should be noted, however, that a more severe type of hypotensive reaction associated with flush, bradycardia, and dyspnea was reported in patients taking concomitant angiotensin converting enzyme (ACE) inhibitor medication. Except for such anaphylactoid-like reactions associated with the intake of ACE inhibitors, the Liposorber LA-15 system represents a safe and effective therapeutic option for patients suffering from severe hypercholesterolemia that could not be adequately controlled by diet and maximum drug therapy.
Blood purification therapies using dextran sulfate cellulose columns Liposorber and Selesorb. [2022]Liposorber is a column used for plasma purification that adsorbs low-density lipoproteins with high selectivity, while Selesorb is a column that selectively adsorbs anti-DNA antibodies, anticardiolipin antibodies, and immune complexes. Both columns are packed with carriers, where a dextran sulfate ligand is bound to porous cellulose beads. Liposorber is used to treat familial hypercholesterolemia (FH), peripheral arterial disease (PAD), and focal segmental glomerulosclerosis (FGS): Selesorb is used to treat systemic lupus erythematosus (SLE). Treatment utilizing both columns is being used effectively in patients with refractory disease that is resistant to pharmacotherapy.
Adsorption of lipoprotein containing apolipoprotein-B through plasma separation for treatment of familial hypercholesterolemia. [2017]For the treatment of familial hypercholesterolemia, Liposorber LA-40 was clinically applied. The Liposorber is a commercially developed affinity adsorbent for plasma perfusion which selectivity adsorbs low density lipoproteins and very low density lipoproteins and is specially designed for plasmapheretic treatment of hypercholesterolemia. The Liposorber column, containing activated cellulose beads having an affinity for lipoprotein containing apolipoprotein-B, has an excellent adsorption capacity, excellent selectivity, minimum albumin loss. This new apheresis system was applied to 2 clinical cases. After seven months of trial perfusion every 2 weeks, patient condition was good, with a level of total cholesterol under 300 mg/dl. No replacement fluids were given during or after treatment. In this paper, clinical results of these patients were shown and the mechanism of adsorption of this specific adsorbent was discussed.
Low-density lipoprotein apheresis using the Liposorber dextran sulfate cellulose system for patients with hypercholesterolemia refractory to medical therapy. [2005]A subset of patients with familial hypercholesterolemia (FH) have an inadequate lipid-lowering response to diet and drug treatment and should be considered for low-density lipoprotein (LDL)-apheresis therapy. This procedure selectively removes apolipoprotein B-containing particles [LDL, very-low-density lipoprotein, lipoprotein(a)] from plasma independent of diet and drug therapy. Methods for performing LDL-apheresis include dextran sulfate cellulose adsorption, immunoadsorption, and heparin-induced extracorporeal precipitation. The Liposorber Study Group evaluated LDL removal using the Liposorber LA-15 LDL-apheresis System in 64 patients with FH who had not responded adequately to diet and maximal drug therapy. Mean acute reductions in LDL cholesterol (LDL-C) were 76% in heterozygous FH (HtFH) patients and 81% in homozygous FH (HoFH) patients. Time-averaged levels of LDL-C were lowered 41% in HtFH and 53% in HoFH patients. Hypotension was the most frequent side effect, occurring in 3% of procedures. The Liposorber LA-15 System has been approved by the Food and Drug Administration and is recommended for 1) patients with functional homozygous FH (LDL-C level > 500 mg/dL; 2) patients with coronary artery disease (CAD) and LDL-C levels > or = 200 mg/dL; 3) patients without CAD, but an LDL-C level > or = 300 mg/dL.
Chronic kidney disease predictors in obese adolescents. [2022]Glomerular hyperfiltration, initiating development of obesity-related glomerulopathy, results in an enlargement of the glomeruli and unsealing of the filtration barrier. It can be followed by adaptive focal segmental glomerulosclerosis and chronic kidney disease (CKD). The aim of the study was to determine the expression pattern of lipid metabolism and selected kidney damage markers in obese adolescents and to identify potential factors which can predict CKD.
Treatment and prognosis of primary focal segmental glomerulosclerosis. [2013]This study aimed to analyze the treatment, clinical outcomes, and risk factors that affect the prognosis of patients with primary focal segmental glomerulosclerosis (FSGS) and to provide theoretical evidence for various treatment options in these patients. The study reviewed the clinical, laboratory, and pathological data of 168 patients with primary FSGS treated at Ruijin Hospital between January 2002 and October 2011. Of these patients, 108 were male (64.3%) and 60 were female (35.7%). The median age of disease onset was 38 years (range 12-78 years). The median case history was 10 months (range 4 days to 30 years). The mean proteinuria level was 2.3 ± 0.6 g/day. 75 (44.6%) patients had nephrotic syndrome. The mean serum creatinine was 108.1 ± 8.9 μmol/l. Over a follow-up period of 25.3 ± 11.4 months, end-stage renal failure occurred in 4 patients, and all 4 survived. In the group treated with angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, the following factors were identified as risk factors for experiencing a 50% increase in serum creatinine over the baseline: a baseline eGFR 1 g/day during the follow-up period, glomerular sclerosis >grade 1, and tubulointerstitial lesions >stage 1. In the group treated with steroids, patients who achieved a stable remission had better preserved renal function and milder glomerular sclerosis than steroid-dependent patients (p
Proteinuria and focal segmental glomerulosclerosis in severely obese adolescents. [2022]To describe the clinical and laboratory features of obesity associated proteinuria and focal segmental glomerulosclerosis.
Aggressive treatment of severe idiopathic focal segmental glomerulosclerosis. [2022]When focal segmental glomerulosclerosis (FSGS) has reached the stage of chronic renal insufficiency, further progression is usually considered inevitable. African-American patients are believed to exhibit a particularly aggressive form of FSGS. We have treated five African-American patients, aged 11-18 years, with FSGS and reduced renal function using intensive intravenous methylprednisolone protocol, combined with chlorambucil in three cases. All patients had a pretreatment creatinine clearance of less than 50 ml/min per 1.73 m2. Three patients responded with normalization of creatinine clearance and serum albumin levels and had no or only minimal proteinuria at latest follow-up. One patient showed no improvement and one patient progressed to end-stage renal disease. These findings indicate, for the first time, that even severe FSGS may respond to aggressive methylprednisolone with or without alkylating agent treatment, and that African-American race does not preclude a favorable response.
Effects of steroids in focal segmental glomerulosclerosis in a predominantly African-American population. [2022]Focal segmental glomerulosclerosis (FSGS) is a common primary glomerulopathy in African Americans. Prolonged treatment with steroids is recommended for FSGS in those with nephrotic-range proteinuria, but strong evidence for this recommendation, especially in African-American adults, is lacking. We reviewed our experience with steroids in FSGS in a predominantly African-American cohort.