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• W2955134627 abstract "Focal segmental glomerulosclerosis (FSGS) is the major cause of end stage renal disease (ESRD) in the United States and worldwide. Primary FSGS carries poor prognosis as spontaneous remission is rare and more rapidly progress to ESRD within 2-8 years in nephrotic range proteinuria patients. Management of FSGS patients refractory to standard treatments or resistant to steroids remains a major challenge. Low-density lipoprotein apheresis (LDL apheresis) is a novel therapy for drug resistant (corticosteroids and/or calcineurin inhibitors) primary FSGS and post-renal transplant primary FSGS recurrence. The objective of this study is 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 NS due to refractory primary FSGS, or primary FSGS associated NS in post renal transplant children. Prospective, multicenter, single-arm intervention study using Liposorber®LA-15 system. Study was initiated in July 2014 with expected enrollment completion in August 2018. Patients ≤21 years old with drug resistant or drug intolerant NS secondary to primary FSGS with glomerular filtration rate (GFR) ≥60 ml/min/1.73m2or post renal transplant patients ≤21 years old with primary FSGS associated NS were included in the study. Each patient will have a total of 12 apheresis sessions with Liposorber®LA-15 system over a period of 9 weeks. All the patients will be followed up at 1, 3, 6, 12 and 24 months following completion of apheresis treatment. As of October 2017, 14 patients from 6 sites have been enrolled in to the study. A total of 11 patients completed 12 apheresis treatments over a period of 9 weeks. At one-month follow-up, 1 of 4 patients (25%) attained partial remission of NS. Furthermore, 2 of 3 subjects (33.3%) and 2 of 2 subjects (100%) had partial/complete remission at 3 and 6 months follow-up respectively. Only one patient who was followed up for 12 months had complete remission of NS. Improvement or stable eGFR was noted in all the patients (100%) over the follow-up period. In line with other previous studies, short-term 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. However, these are interim results and full analysis after completion of the study will shed more light on the outcome of LDL apheresis in this patient population." @default.
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• W2955134627 date "2019-07-01" @default.
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• W2955134627 title "SUN-034 Liposorber® LA-15 system for LDL apheresis in drug resistant primary focal segmental glomerulosclerosis patients: Interim results from a prospective, multicenter, single-arm intervention study" @default.
• W2955134627 doi "https://doi.org/10.1016/j.ekir.2019.05.429" @default.
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