Evidence map›Paper›PMID 34380536›Full record

ArticleTrials2021

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).

Qingran Yan, Fang Du, Yuening Kang, Ping Ye, Xiaodong Wang, Jianhua Xu, Jianping Tang, Niansong Wang, Gengru Jiang, Zhijun Li and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02936375 (The Effect of Iguratimod on Active Lupus Nephritis, the IGeLU Study), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02936375 phase2unknown statusnot on this map

The Effect of Iguratimod on Active Lupus Nephritis, the IGeLU Study: a Randomized Controlled Trial

TypeinterventionalSponsorRenJi HospitalRan2017 to 2021Enrolled120ConditionsLupus NephritisArmsIguratimod, Cyclophosphamide, Azathioprine, Steroids
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 8 institutions in 1 country.

Qingran Yan *Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China. yanqingran@163.com.
Fang Du *Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.
Yuening Kang *Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.
Ping YeDepartment of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.
Xiaodong WangDepartment of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.
Jianhua XuDepartment of Rheumatology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, China.
Jianping TangDepartment of Rheumatology and Immunology, Tongji Hospital, Tongji University School of Medicine, Shanghai, 200065, China.
Niansong WangDepartment of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.
Gengru JiangRenal Division, Department of Internal Medicine, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China.
Zhijun LiDepartment of Rheumatology and Immunology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, 233004, Anhui, China.
Xuan WangDepartment of Rheumatology and Immunology, Tongji Hospital, Tongji University School of Medicine, Shanghai, 200065, China.
Qin XueDepartment of Nephrology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.
Xinfang HuangDepartment of Rheumatology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, 200120, China.
Xiaoyan ZhangRenal Division, Department of Internal Medicine, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China.
Ying ZhouDepartment of Rheumatology and Immunology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, 233004, Anhui, China.
Min DaiDepartment of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China. maverickdai@sina.com.
Chunde BaoDepartment of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China. baochunde_1678@126.com.
Renji Hospital · CNFirst Affiliated Hospital of Bengbu Medical College · CNShanghai Sixth People's Hospital · CNXinHua Hospital · CNAnhui Medical University · CNShanghai East Hospital · CNTongji Hospital · CNTongji University · CN

Funding

Shanghai Municipal Population and Family Planning Commission 20204Y0088Shanghai Shenkang Promoting Project 16CR1027B
6 · The paper itself

Abstract

backgroundSystemic 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/

designThis 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 registrationClinicalTrials.gov NCT02936375 . Registered on October 18, 2016.

Indexed as

AzathioprineLupus NephritisChromonesCyclophosphamideHumansImmunosuppressive AgentsMulticenter Studies as TopicRandomized Controlled Trials as TopicRemission InductionSulfonamidesTreatment OutcomeAzathioprineChromonesCyclophosphamideiguratimodImmunosuppressive AgentsSulfonamidesActive lupus nephritisCyclophosphamideIguratimodRandomized clinical trialSystemic lupus erythematosustreatment

Identifiers

PMID34380536
PMCPMC8356213
OpenAlexW3188225542

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.