Indications For Use - Primary FSGS
The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis when:
- standard treatment options, including corticosteroids and/or calcineurin inhibitor treatments, are unsuccessful or not well tolerated and the patient’s glomerular filtration rate (GFR) ≥ 60 ml/min/1.73 m2 -or-
- the patient is post renal transplantation.1
How LIPOSORBER® Works
- Blood is withdrawn and goes through the plasma separator.
- Plasma passes through the LIPOSORBER Adsorption Column, selectively removing LDL, Lp(a) and VLDL.
- Plasma is recombined with blood cells and passes through the blood warmer, then is returned to the patient.
- After the first cycle is complete, the computer-regulated machine automatically switches the plasma flow from the primary LIPOSORBER Adsorption Column to the secondary column after 600 ml of blood has been processed.
- The primary column is regenerated, eluting waste and re-primed to be ready for the next cycle of adsorption.
Selectivity & Efficacy
Selectivity Feature
The adsorbent columns are made of dextran sulfate cellulose beads, which provides specific binding to Apo-B containing lipoproteins such as LDL-C, Lp(a), and VLDL.1
These three are selectively removed by the electro-static interaction between the negatively charged dextran sulfate and the positively charged moiety of Apo-B. Unlike therapeutic plasma exchange (TPE), LIPOSORBER minimally affects other blood components.1
By effectively decreasing total cholesterol and LDL-C, LIPOSORBER promotes:
- Direct podocytes effects: Decreases lipotoxicity to the glomeruli3
- Immunologic effects: Improves response to corticosteroid and cyclosporine4
- Anti-inflammatory effects (e.g., IFN-γ and IL-12): Removal of pro-inflammatory factors, such as cytokines and chemokines5
Potential Effectiveness
Studies suggest that treatment with LIPOSORBER may:*
Improve response to corticosteroids: Lipoprotein-apheresis (LA) therapy corticosteroid and cyclosporine action and responsiveness in patients with drug resistance, which is likely due to the restoration of cellular uptake and the inhibition of drug efflux.4
Reduce urine protein levels: LIPOSORBER therapy has induced complete or partial remission of proteinuria in up to 50% of patients with drug-resistant FSGS.2
Improve renal functions: Enabled nearly 50% of steroid-resistant primary FSGS patients to attain complete or partial remission2**
Reduce LDL-C, Lp(a), TG in blood: LIPOSORBER therapy has the potential to preserve the graft and prevent restarting of dialysis.6
*The content of the studies and their relevant features (e.g., LIPOSORBER or similar product, number of participants, controlled study, independent study, etc.) may be found in references 2, 4 and 6, cited below.
**Study duration took place over two (2) years.
Demonstrated Clinical Record
- Well-tolerated by the majority of patients who have received treatment.
- In Japan, LIPOSORBER® treatment for FSGS has been covered by both Public Health Insurance and Employees’ Health Insurance (EHI) since 1992.
- In 2013, LIPOSORBER® was approved for use in the U.S. by the FDA for nephrotic syndrome associated with primary FSGS (IRB approval required under HUD designation prior to treatment) for Health Care Professionals.
Side Effects1
ADVERSE EVENTS: The most common adverse events are hypotension (0.8%), nausea/vomiting (0.5%), and flushing/blotching (0.4%). Other adverse reactions include angina/chest pain, shortness of breath, fainting, lightheadedness and anemia.
CONTRAINDICATION: Angiotensin converting enzyme [ACEI(s)] inhibitors are contraindicated with LIPOSORBER® due to possible bradykinin reaction. ACEI(s) should be replaced with angiotensin II receptor blockers (ARBs) or any other antihypertensive agent as determined by the prescribing physician.
For complete safety information, including adverse events and contraindications, please refer to the Instructions For Use manual: bit.ly/31UDfnC
LIPOSORBER® Provides Hope When Drug Therapy FailsTM
LIPOSORBER therapy has enabled nearly 50% of steroid-resistant primary FSGS patients to attain complete or partial remission, 2 years after treatment.3
References:
- Kaneka Medical America LLC., 2021, LIPOSORBER®LA-15 SYSTEM Operator’s Manual No.1002en-R4.
- Muso, E et al. “Immediate therapeutic efficacy of LDL apheresis for drug-resistant nephrotic Syndrome: evidence from the short-term results from the POLARIS Study.” Clinical and experimental nephrology vol. 19,3 (2015): 379-86. doi:10.1007/s10157-014-0996-8
- Raina, Rupesh et al. “Extracorporeal Therapies in the Treatment of Focal Segmental Glomerulosclerosis.” Blood purification vol. 49,5 (2020): 513-523. doi:10.1159/000506277
- Muso, E “Beneficial effect of LDL-apheresis in refractory nephrotic syndrome.” Clinical and experimental nephrology vol. 18,2 (2014): 286-90. doi:10.1007/s10157-013-0930-5
- Miyata, Hitomi et al. “Low density lipoprotein apheresis ameliorates interferon-γ production in patients with nephrotic syndrome.” Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy vol. 16,2 (2012): 189-94. doi:10.1111/j.1744-9987.2011.01045.
- Shah, Lokesh et al. “LDL-apheresis-induced remission of focal segmental glomerulosclerosis recurrence in pediatric renal transplant recipients.” Pediatric nephrology (Berlin, Germany) vol. 34,11 (2019): 2343-2350. doi:10.1007/s00467-019-04296-6
