Academic Journal

#4049 NEFECON® TREATMENT LIKELY MODULATES DOWNSTREAM PATHWAYS OF KIDNEY INFLAMMATION AND FIBROSIS IN IGA NEPHROPATHY

التفاصيل البيبلوغرافية
العنوان: #4049 NEFECON® TREATMENT LIKELY MODULATES DOWNSTREAM PATHWAYS OF KIDNEY INFLAMMATION AND FIBROSIS IN IGA NEPHROPATHY
المؤلفون: Molyneux, Karen, Nawaz, Nadia, Wolski, Witold, Pfammatter, Sibylle, Kunz, Laura, Barratt, Jonathan
المصدر: Nephrology Dialysis Transplantation ; volume 38, issue Supplement_1 ; ISSN 0931-0509 1460-2385
بيانات النشر: Oxford University Press (OUP)
سنة النشر: 2023
مصطلحات موضوعية: Transplantation, Nephrology
الوصف: Background and Aims The lifetime risk of kidney failure in patients with IgA nephropathy (IgAN) is substantial. Since the original description of the disease, over 50 years ago, there has been little progress in how we manage this important cause of kidney failure in young adults. KDIGO 2021 Clinical Practice Guidelines recommend goal-directed supportive care as the treatment with the strongest evidence base for the management of all patients with IgAN. The NEFIGAN trial (NCT01738035) tested the safety and efficacy of a novel targeted-release formulation of budesonide (Nefecon®), designed to deliver budesonide to the gut-associated lymphoid tissue-rich distal ileum in patients with IgAN in addition to optimised supportive care. The trial comprised a 6-month run-in, 9-month treatment, and a 3-month follow-up phase. Forty-eight patients received Nefecon® 16 mg/day, 51 patients received Nefecon® 8 mg/day, and 50 patients received placebo. The headline result of the study was that Nefecon® 16 mg/day, added to optimised RAS blockade, reduced proteinuria and stabilised eGFR in patients with IgAN. These findings have now been replicated in the NefIgArd study, which reported in 2021 and provided the basis for the recent FDA and EMA approval of Nefecon® as a treatment for patients with IgAN at high risk of progressive disease. In this study, we determined the composition of urinary proteins from patients treated with placebo and 16 mg of Nefecon® in the NEFIGAN trial using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Method Urine samples from 18 patients from each of the placebo and 16-mg arms of the NEFIGAN trial collected at the start of treatment (SOT) and end of treatment (EOT) were analysed. Patients were only included if they had received at least 8 months of treatment and their urine sample was taken up to 2 days after the completion of tapering. Urine samples were treated to remove abundant albumin and immunoglobulins. The remaining proteins were desalted and then precipitated with 5% ...
نوع الوثيقة: article in journal/newspaper
اللغة: English
DOI: 10.1093/ndt/gfad063c_4049
الاتاحة: http://dx.doi.org/10.1093/ndt/gfad063c_4049
https://academic.oup.com/ndt/article-pdf/38/Supplement_1/gfad063c_4049/50673063/gfad063c_4049.pdf
Rights: https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model
رقم الانضمام: edsbas.577F4CDD
قاعدة البيانات: BASE
الوصف
DOI:10.1093/ndt/gfad063c_4049