Yan Bingjuan, Tie Xuan, Wang Lihua, Qiao Xi, Su Xiaole
Department of Nephrology, Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Shanxi Kidney Disease Institute, Taiyuan, Shanxi, China.
BMJ Open. 2025 Apr 27;15(4):e098688. doi: 10.1136/bmjopen-2024-098688.
The management of immunoglobulin A (IgA) nephropathy remains a topic of debate. Hydroxychloroquine and mycophenolate mofetil (MMF) are two immunosuppressive agents that have recently garnered increased attention among patients with IgA nephropathy in China. Several studies have shown the comparable efficacy between MMF and enteric-coated mycophenolate sodium (EC-MPS), with lower adverse event rates for EC-MPS. The present study aims to evaluate the efficacy and safety of EC-MPS combined with hydroxychloroquine as an immunosuppressive regimen for patients with high-risk progressive IgA nephropathy, despite receiving routine supportive treatment.
This study is a multicentre, prospective, randomised controlled, open-label, blinded endpoint trial. 96 patients diagnosed with IgA nephropathy and persistent proteinuria from 12 general hospitals in Shanxi Province of China will be recruited and randomly assigned to receive either EC-MPS plus hydroxychloroquine or hydroxychloroquine alone in a 1:1 ratio. We will compare the efficacy and safety of hydroxychloroquine combined with or without oral EC-MPS (720-1080 mg/day for 6 months, and tapered to 360-540 mg/day for another 6 months) on a background of supportive care. All enrolled patients will receive standard basic treatment to achieve optimum blood pressure and the maximum tolerated dose of ACE inhibitors or angiotensin receptor blockers. The primary outcome is the change in 24-hour urine protein at 6 months relative to baseline. Participants will be subject to regular follow-up for a duration of 12 months.
This study has received ethical approval from the Ethics Committee of Shanxi Medical University Second Hospital (No. 2024YX-481). A duly signed and dated informed consent form must be obtained from each participant or his/her legal guardian prior to any operational procedures related to the trial. The result of this study will be presented and published at international conferences and in scientific journals.
ChiCTR2400093530.
免疫球蛋白A（IgA）肾病的治疗仍是一个有争议的话题。羟氯喹和霉酚酸酯（MMF）是两种免疫抑制剂，最近在中国IgA肾病患者中受到越来越多的关注。多项研究表明，MMF与肠溶型霉酚酸钠（EC-MPS）疗效相当，而EC-MPS的不良事件发生率更低。本研究旨在评估EC-MPS联合羟氯喹作为免疫抑制方案用于高危进展性IgA肾病患者（尽管接受了常规支持治疗）的疗效和安全性。
本研究是一项多中心、前瞻性、随机对照、开放标签、盲终点试验。将从中国山西省12家综合医院招募96例诊断为IgA肾病且有持续性蛋白尿的患者，并按1:1比例随机分配接受EC-MPS加羟氯喹或单纯羟氯喹治疗。我们将比较在支持治疗背景下，羟氯喹联合或不联合口服EC-MPS（720 - 1080毫克/天，持续6个月，之后减至360 - 540毫克/天，再持续6个月）的疗效和安全性。所有入组患者将接受标准基础治疗，以达到最佳血压水平，并使用最大耐受剂量的血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂。主要结局是6个月时24小时尿蛋白相对于基线的变化。参与者将接受为期12个月的定期随访。
本研究已获得山西医科大学第二医院伦理委员会的伦理批准（编号：2024YX - 481）。在进行与试验相关的任何操作程序之前，必须从每位参与者或其法定监护人处获得正式签署并注明日期的知情同意书。本研究结果将在国际会议和科学期刊上展示和发表。
ChiCTR2400093530。
