泼尼松龙治疗急性间质性肾炎（PRAISE）随机对照试验方案。
Prednisolone treatment in acute interstitial nephritis (PRAISE) - protocol for the randomized controlled trial.
机构信息
University Clinic in Nephrology and Hypertension, Aarhus University and Gødstrup Hospital, Herning, Denmark.
Department of Medicine, Gødstrup Hospital, Herning, Denmark.
出版信息
BMC Nephrol. 2021 May 1;22(1):161. doi: 10.1186/s12882-021-02372-4.
BACKGROUND
Acute interstitial nephritis (AIN) is an important and common cause of acute renal failure. There are no generally accepted guidelines for the treatment of AIN, due to the lack of prospective randomized trials. Since AIN is characterized by an enhanced immune response, immunosuppressive treatment could potentially improve prognosis by attenuating inflammation and subsequent fibrosis. Despite the limited evidence of effects of steroids and potential adverse effects, prednisolone is frequently used in the treatment of AIN and there is a strong need for clinical trials on the effects of immunosuppression, including steroids, in the treatment of AIN. We aimed to evaluate the effectiveness of prednisolone treatment in AIN, and hypothesized a positive effect of prednisolone treatment on renal function in AIN.
METHODS
The study is a randomized, controlled, prospective, open label multicenter study, including incident adult patients with biopsy proven AIN. Patients will be randomized 1:1 to one of 2 treatment regimens: A. No prednisolone treatment (control group) and B. B) Oral prednisolone treatment staring with 60 mg daily tapered over 8 weeks. One hundred ten patients (55 in each group) are planned to be included and followed for 1 year. Primary outcome is renal function estimated by eGFR 3 months after inclusion. Secondary outcomes are renal function after 12 months and need for renal replacement therapy and quality of life after 3 and 12 months. In addition, with-in prednisolone group analysis are performed to estimate the importance of treatment delay. Exploratory analyses include analysis of biomarkers in urine and plasma and the evaluation of these biomarkers in relation to renal prognosis and re-evaluation of renal biopsies to identify possible renal prognostic factors.
DISCUSSION
Strengths and possible limitations in the design are evaluated. The study will provide important information on the effects of prednisolone treatment in AIN and as well as prognostic information relevant for future use of biomarkers and histology. Ultimately, this would lead to improved and evidence based clinical guidelines for the treatment of AIN.
TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT04376216 (Retrospectively registered on May 6, 2020).
背景
急性间质性肾炎（AIN）是急性肾衰竭的一个重要且常见的原因。由于缺乏前瞻性随机试验，目前尚没有普遍接受的 AIN 治疗指南。由于 AIN 的特征是增强的免疫反应，免疫抑制治疗通过减轻炎症和随后的纤维化，可能改善预后。尽管类固醇的疗效证据有限且可能存在不良反应，但泼尼松龙在 AIN 的治疗中经常被使用，因此强烈需要关于免疫抑制（包括类固醇）治疗 AIN 的临床试验。我们旨在评估泼尼松龙治疗 AIN 的疗效，并假设泼尼松龙治疗对 AIN 患者肾功能有积极影响。
方法
该研究是一项随机、对照、前瞻性、开放标签的多中心研究，包括经活检证实的 AIN 成年患者。患者将以 1:1 的比例随机分为两组治疗方案：A. 不使用泼尼松龙治疗（对照组）和 B. B）口服泼尼松龙治疗，起始剂量为 60mg/天，8 周内逐渐减量。计划纳入 110 例患者（每组 55 例），随访 1 年。主要结局是纳入后 3 个月时通过 eGFR 估计的肾功能。次要结局是 12 个月时的肾功能以及是否需要肾脏替代治疗和 3 个月和 12 个月时的生活质量。此外，在泼尼松龙组内分析中，还进行了治疗延迟的重要性评估。探索性分析包括尿液和血浆生物标志物的分析，以及这些生物标志物与肾脏预后的关系，并重新评估肾活检以确定可能的肾脏预后因素。
讨论
对设计的优势和可能的局限性进行了评估。该研究将提供关于泼尼松龙治疗 AIN 的疗效以及与未来使用生物标志物和组织学相关的预后信息方面的重要信息。最终，这将导致改善和基于证据的 AIN 治疗临床指南。
试验注册
ClinicalTrials.gov 标识符 NCT04376216（2020 年 5 月 6 日回顾性注册）。
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