Comparison of iguratimod and conventional cyclophosphamide with sequential azathioprine as treatment of active lupus nephritis: study protocol for a multi-center, randomized, controlled clinical trial (iGeLU study)

Trials

Niansong Wang¹  Qin Xue¹  Zhijun Li²  Ying Zhou²  Xuan Wang³  Jianping Tang³  Ping Ye⁴  Fang Du⁴  Yuening Kang⁴  Chunde Bao⁴  Qingran Yan⁴  Min Dai⁴  Xiaodong Wang⁴  Xinfang Huang⁵  Jianhua Xu⁶  Gengru Jiang⁷  Xiaoyan Zhang⁷ 

[1] Department of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital;Department of Rheumatology and Immunology, The First Affiliated Hospital of Bengbu Medical College;Department of Rheumatology and Immunology, Tongji Hospital, Tongji University School of Medicine;Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University;Department of Rheumatology, Shanghai East Hospital, School of Medicine, Tongji University;Department of Rheumatology, The First Affiliated Hospital of Anhui Medical University;Renal Division, Department of Internal Medicine, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine;

关键词: Systemic lupus erythematosus;    Active lupus nephritis;    Randomized clinical trial;    Iguratimod;    Cyclophosphamide;    treatment;   

DOI  :  10.1186/s13063-021-05475-3

来源: DOAJ

【 摘 要 】

Abstract Background Systemic lupus erythematosus (SLE) is an autoimmune disease that can involve multiple organs or systems. Lupus nephritis (LN) is associated with high mortality and morbidity. However, plenty of patients do not respond to present treatment or relapse. Iguratimod (IGU) is a new small molecular, anti-rheumatic drug and has shown the potential for drug repurposing from rheumatoid arthritis (RA) to LN treatment. It has been approved for treating RA in northeast Asia. Beyond expectation in a recent observational study, over 90% of thirteen refractory LN patients responded to iguratimod monotherapy in 24 weeks, with no steroids dose increasing or any other medication add-on during the entire follow-up. Methods/design This study is a multi-center, randomized, 52-week parallel positive drug-controlled study. The study was designed as a head-to-head comparison between the iguratimod and present first-line therapy on LN patients. A total of 120 patients (60 patients each group) is in the enrolling plan. All enrolled patients are assigned randomly into trial and control groups. The patients will be selected from six study sites in China and will all have biopsy-proven active lupus nephritis. In the first 24 weeks of the trial, IGU is compared with cyclophosphamide as an induction therapy, and in the second 24 weeks, IGU is compared with azathioprine as a maintenance therapy. The primary outcome is renal remission rate including both complete remission and partial remission at week 52, which will be analyzed using a non-inferiority hypothesis test. Discussion Most patients diagnosed with SLE will develop LN within 5 years and LN remains a major cause of morbidity and death for SLE patients. Although some medications are proven effective for the treatment of this condition, at least 20–35% LN patients have to suffer from relapse or ineffective treatment and medication intolerance is also frequent. This trial is designed to demonstrate whether iguratimod can be used as an alternative induction or maintenance therapy in subjects who have lupus nephritis. Data from this study will provide an evidence on whether or not iguratimod should be recommended to active LN patients. Trial registration ClinicalTrials.gov NCT 02936375 . Registered on October 18, 2016.

【 授权许可】

Unknown