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Background IgA nephropathy (IgAN) is the most common primary glomerulonephritis worldwide. Approximately 30–40% of patients progress to end-stage renal disease over 20 years. Mucosal immune dysregulation in nasal-associated lymphoid tissue (NALT) may be involved in the pathogenesis of IgAN. In Japan, the efficacy of tonsillectomy combined with steroid pulse therapy (TSP) has been reported. Meanwhile, the risk of surgery i.e., tonsillectomy and the adverse effects related to systemic steroid administration are major concerns for TSP. To overcome these problems, we propose a topical steroid therapy targeting NALT. This therapeutic concept is a novel approach to regulate the mucosal immunity of NALT. In this study, we aim to evaluate the safety and efficacy of dexamethasone-based elixir gargling in patients with IgAN. Methods This will be a single-centre, open-label, historical controlled study. We plan to enroll 20 patients diagnosed with IgAN who were scheduled to undergo tonsillectomy. All participants are required to sign a written consent form. The study protocol has been reviewed and approved by Juntendo University Hospital Certified Review Board (CRB3180012). Patients will receive steroid gargling therapy with 10 ml of 0.01% undiluted solution of dexamethasone elixir four times per day for 4 weeks. The primary endpoint is the safety of steroid gargling, including the incidence of adverse events (oral/pharyngeal discomfort and taste disorders), presence of elevated inflammatory markers and presence of glucose intolerance. The secondary endpoint is the efficacy of steroid gargling, including serum IgA and galactose-deficient IgA1 (Gd-IgA1) level, renal function, proteinuria and haematuria. All statistical analyses will be conducted using the SAS statistical software (version 9.4, SAS Institute, Cary, NC, USA). Discussion There are few reports of intra-oral, topical steroids in renal disease. Once the steroid gargle is evaluated as safe in this study, extending the gargling period for longer term—for example 3 to 6 months—would be considered in the subsequent large-scale study. This pilot trial would also help in assessing the financial, technical, administrative, or logistic feasibility of a larger study. Trial registration number Japan Registry of Clinical Trials (jRCTs031200127). https://jrct.niph.go.jp/latest-detail/jRCTs031200127. Protocol version: October 15, 2021 Ver. 1.3. The date of registration 09/23/2020 |
