{
  "abstract": "Introduction\n\nIgA nephropathy (IgAN) is the most common primary glomerulonephritis worldwide and a leading cause of end-stage kidney disease. Targeted-release formulation (TRF) budesonide demonstrated significant reductions in proteinuria and attenuation of estimated glomerular filtration rate (eGFR) decline in the randomised NefIgArd trial. However, real-world effectiveness and tolerability in routine clinical practice remain less well characterised. We report real-world outcomes following initiation of TRF budesonide in a tertiary renal centre.Methods\n\nWe conducted a retrospective cohort study of all patients with biopsy-proven IgAN initiated on TRF budesonide between 1st January 2024 and 31st July 2025 at a single renal centre in the UK, with follow-up until 31st January 2026. Outcomes were changes in urine protein-to-creatinine ratio (UPCR) and eGFR from baseline to 3, 6, and 9 months and to the latest follow-up, assessed within patients using the Wilcoxon signed rank test. Intention-to-treat (ITT; all 33 patients commencing therapy) and per-protocol (PP; ≥6 months of therapy and not switched directly from modified-release budesonide) analyses were performed. Pre- and post-treatment eGFR slopes were compared using linear mixed-effects models, and a historical comparator cohort matched on baseline UPCR was drawn from the Salford Kidney Study; both are reported as exploratory.Results\n\nThirty-three patients commenced TRF budesonide, of whom 23 met PP criteria. Median age was 44 (IQR 37-60) years, baseline UPCR 212 (133-289) mg/mmol, and eGFR 48 (30-61) mL/min/1.73 m2. Renin-angiotensin system (RAS) inhibitor and sodium-glucose cotransporter-2 (SGLT2) inhibitor use were 94% and 91%, respectively. At the latest follow-up (median 11.2 months after treatment initiation), UPCR decreased by 60% (IQR 31-71%) in the ITT cohort (p < 0.001) and 57% (IQR 26-72%) in the PP cohort (p < 0.001). eGFR was stable across the treatment period, with no significant change from baseline at 9 months or at the latest follow-up in either analysis set. Pre- to post-treatment slope comparison was confounded by initiation of SGLT2 inhibitor therapy within the pre-treatment observation window and is reported as exploratory. An adverse effect was recorded in 9 of 33 patients (27%). Seven patients (21%) discontinued treatment, 6 for non-serious adverse effects and 1 for a serious adverse event (staphylococcal septicaemia requiring hospital admission); treatment was temporarily suspended in 1 further patient.Conclusion\n\nIn a real-world IgAN cohort with near-universal RAS and SGLT2 inhibitor use, TRF budesonide was associated with substantial proteinuria reduction, additive to optimised background therapy. eGFR was stable over the treatment period. Slope-based analyses could not be interpreted, because background SGLT2 inhibitor therapy was initiated within the pre-treatment observation window in nearly every patient. Discontinuation for adverse effects was more frequent than in trials, though symptoms were generally mild; adverse event frequencies are not directly comparable given retrospective ascertainment.",
  "abstract_shown": true,
  "affiliations": [
    "Renal Department, Northern Care Alliance NHS Foundation Trust, Salford, UK.",
    "Division of Cardiovascular Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.",
    "Renal Department, Northern Care Alliance NHS Foundation Trust, Salford, UK, william.marshall-6@postgrad.manchester.ac.uk.",
    "Division of Cardiovascular Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK, william.marshall-6@postgrad.manchester.ac.uk."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 7,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Thomas McDonnell"
    },
    {
      "affs": [
        2,
        3
      ],
      "name": "William R Marshall",
      "orcid": "0009-0004-4764-8944"
    },
    {
      "affs": [
        0
      ],
      "name": "Sharmilee Rengarajan"
    },
    {
      "affs": [
        0
      ],
      "name": "Jude Allen"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Rajkumar Chinnadurai"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Smeeta Sinha",
      "orcid": "0000-0003-4117-4085"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Philip A Kalra"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/bqrg50g581j7f.bib",
  "cited_by": 0,
  "doi": "10.1159/ajn/ablag015",
  "fulltext_url": "https://europepmc.org/articles/PMC13686600",
  "id": "bqrg50g581j7f",
  "issns": [
    "0250-8095",
    "1421-9670"
  ],
  "landing_url": "https://europepmc.org/article/MED/42879331",
  "language": "eng",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2727|Renal Diseases and Glomerulopathies"
    ]
  ],
  "openalex": "W7222145849",
  "pdf_url": "https://karger.com/ajn/article-pdf/doi/10.1159/ajn/ablag015/4595046/000554841.pdf",
  "pmcid": "PMC13686600",
  "pmid": "42879331",
  "published": "2026-10-15",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/bqrg50g581j7f.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:18:46Z",
      "native_id": "MED:42879331",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42879331"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2727|Renal Diseases and Glomerulopathies",
      "subfield": "general"
    }
  ],
  "title": "Real-World Effectiveness of Targeted-Release Budesonide in IgA Nephropathy with Near-Universal SGLT2 Inhibitor Use.",
  "title_text": "Real-World Effectiveness of Targeted-Release Budesonide in IgA Nephropathy with Near-Universal SGLT2 Inhibitor Use.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:18:46Z",
  "url": "https://research.draconitic.com/paper/bqrg50g581j7f",
  "venue": "American journal of nephrology",
  "versions": []
}