Leflunomide plus low-dose prednisone in patients with progressive IgA nephropathy: a multicenter, prospective, randomized, open-labeled, and controlled trial

Renal Failure

Min Sun¹  Fuming Lu²  Yueyi Deng³  Zhen Zhang⁴  Zhaohui Ni⁴  Huihua Pang⁴  Zanzhe Yu⁴  Jiaqi Qian⁴  Changlin Mei⁵  Weijie Yuan⁶  Wei Zhang⁷  Liqun He⁸  Gengru Jiang⁹  Xiaoqiang Ding^1,10 

[1] Department of Nephrology, Huadong Hospital, Fudan University;Department of Nephrology, Huashan Hospital, Fudan University;Department of Nephrology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine;Department of Nephrology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University;Department of Nephrology, Shanghai Changzheng Hospital, Second Military Medical University;Department of Nephrology, Shanghai General Hospital, Shanghai Jiao Tong University;Department of Nephrology, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University;Department of Nephrology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine;Department of Nephrology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University;Department of Nephrology, Zhongshan Hospital, Fudan University;

关键词: iga nephropathy;    leflunomide;    glucocorticoids;    disease progression;    proteinuria;   

DOI  :  10.1080/0886022X.2021.1963775

来源: DOAJ

【 摘 要 】

Background Immunoglobulin A nephropathy (IgAN) is the most common cause of glomerulonephritis worldwide, and the optimal approach to its treatment remains a significant challenge. Methods We did a prospective, randomized, open-labeled, multicenter, controlled trial, comprised of 3-month run-in, 12-month treatment, and 12-month follow-up phases. After 3-month run-in phase, patients with biopsy-confirmed IgAN at risk of progression were randomly allocated to LEF plus low-dose prednisone (LEF + prednisone group) or conventionally accepted-dose prednisone [prednisone(alone) group] Our primary outcome was 24-h urine protein excretion (UPE) and secondary outcomes were serum albumin (sALB), serum creatinine (Scr), and eGFR. Safety was evaluated in all patients who received the trial medications. Results One hundred and eight patients [59 in LEF + prednisone group, 49 in prednisone (alone) group]were enrolled and finished their treatment and follow-up periods. There is no significant difference in the baseline level between the two groups. Compared with baseline, both groups showed a significant decrease in 24-h UPE (p < 0.01) and increase in sALB (p < 0.01), with stable Scr and eGFR throughout the 12-month treatment period. What’s more, these effects were sustained through the 12-month follow-up period. However, there was no difference in 24-h UPE, sALB, Scr, and eGFR between the two groups (p > 0.05). At 12 months, a difference in overall response rate, relapsing rate, and incidence of adverse events between the two groups was not significant. Conclusions The efficacy and safety of LEF plus low-dose prednisone and conventionally accepted-dose prednisone in the treatment of progressive IgAN are comparable.

【 授权许可】

Unknown