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The Right Patient, the Right Time: New Resource to Help Identify Primary FSGS Patients for LIPOSORBER® Therapy

For patients living with primary focal segmental glomerulosclerosis (FSGS), achieving disease remission can be challenging, particularly when standard therapies fail to deliver the desired response. As nephrologists evaluate treatment options for these complex cases, identifying appropriate candidates for LIPOSORBER® lipoprotein apheresis remains a critical step in supporting timely intervention.

To help simplify the referral process, Kaneka has developed a new FSGS Patient Identifier Referral Guide, designed to assist healthcare providers in recognizing potential candidates for LIPOSORBER therapy and understanding key referral considerations.

LIPOSORBER Therapy in Primary FSGS

Did you know there’s a treatment option for select FSGS patients who do not respond to or tolerate standard treatment options?

LIPOSORBER is FDA-authorized under a Humanitarian Device Exemption (HDE) for the treatment of adult and pediatric patients with nephrotic syndrome associated with primary FSGS when standard therapies have failed or are not tolerated and specific kidney function criteria are met, as well as for patients experiencing recurrent FSGS following renal transplantation.

Unlike therapeutic plasma exchange (TPE), which non-selectively removes plasma components, LIPOSORBER selectively removes apoB-containing lipoproteins, including LDL cholesterol, lipoprotein(a), and VLDL, through targeted adsorption technology. This selective approach is thought to help reduce lipotoxicity and inflammatory mediators while preserving many beneficial plasma proteins.

Studies suggest that LIPOSORBER therapy may help some patients:

  • Lower protein levels in urine
  • Improve response to medications
  • Support kidney function over time

Published clinical data have shown that approximately 50% of patients with drug-resistant or recurrent FSGS achieved complete or partial remission following treatment, with some studies suggesting LIPOSORBER therapy may also enhance responsiveness to corticosteroids and calcineurin inhibitors. *

*Reference: Muso E. Updated evidence of beneficial effect of LDL apheresis for refractory nephrotic syndrome. Ther Apher Dial. 2023;27(5):785–800. doi:10.1111/1744-9987.14056.

Why Patient Identification Matters

One of the biggest challenges in FSGS management is recognizing when patients have progressed beyond the point where standard treatment options alone are sufficient.

Potential LIPOSORBER candidates generally fall into two key groups (see full indications for use here):

      • Patients with primary FSGS and nephrotic syndrome who have failed or cannot tolerate standard therapies, including corticosteroids and/or calcineurin inhibitors.

      • Patients with recurrent FSGS following kidney transplantation.

    For eligible patients, earlier recognition and referral can help ensure they receive appropriate evaluation and consideration for treatment.

    Introducing the FSGS Patient Identifier Referral Guide

    To support referring physicians, Kaneka’s new Referral Guide provides a practical framework for identifying patients who may qualify for LIPOSORBER therapy. The guide outlines key clinical and documentation requirements, helping clinicians navigate the referral process with greater confidence

    Key considerations highlighted in the guide include:

        • Confirmation of primary FSGS with nephrotic syndrome through kidney biopsy and supporting clinical findings.

        • Documentation of failure, intolerance, or contraindication to standard therapies.

        • Verification of glomerular filtration rate (GFR) criteria.

        • Assessment of baseline proteinuria and kidney function.

        • Documentation of post-transplant recurrence when applicable.

        • Confirmation of patient eligibility requirements, including age and weight criteria.

      The guide also includes a streamlined referral algorithm to help physicians determine whether a patient may be an appropriate candidate for Liposorber therapy.

      FSGS Referring Algorithm:

      FSGS Referring Algorithm

      Supporting a Smoother Referral Process

      In addition to clinical guidance, the Referral Guide outlines practical next steps for providers, including patient education, required documentation, referral submission, treatment center coordination, and follow-up planning. Kaneka also offers reimbursement support resources designed to help sites navigate coding, coverage, and operational implementation.

      Access the New Resource

      The FSGS Patient Identifier Referral Guide was created to help referring physicians quickly identify potential candidates and streamline the path to treatment evaluation.

      As awareness of lipoprotein apheresis continues to grow within the nephrology community, ensuring that appropriate patients are recognized and referred remains an important step in expanding access to care.

      Download the new FSGS Patient Identifier Referral Guide to learn more about candidate selection criteria, referral requirements, and practical resources for supporting patients throughout their treatment journey.

      For full LIPOSORBER indications for use and safety information, including contraindications and adverse events, visit the Liposorber Safety Information page: liposorber.com/liposorber-safety-info

       

      Learn more about Focal Segmental Glomerulosclerosis (FSGS) | National Kidney Foundation