{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T07:38:04Z","timestamp":1765611484030,"version":"3.48.0"},"reference-count":39,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2024,3,11]],"date-time":"2024-03-11T00:00:00Z","timestamp":1710115200000},"content-version":"unspecified","delay-in-days":10,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Basic Research Project (Free Exploration) of Shanxi Province","award":["202203021221270"],"award-info":[{"award-number":["202203021221270"]}]},{"name":"\"Yiluqihang & Shenmingyuanyang\" Medical Development and Scientific Research Fund project on kidney diseases","award":["SMYY20220301001"],"award-info":[{"award-number":["SMYY20220301001"]}]},{"name":"the National Science Foundation of China","award":["82000655"],"award-info":[{"award-number":["82000655"]}]},{"name":"Shanxi Province Health Commission Science Fund","award":["2022002"],"award-info":[{"award-number":["2022002"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,2,22]]},"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Several studies have demonstrated that mycophenolate mofetil (MMF) may be an excellent alternative to cyclophosphamide (CYC) or rituximab for the induction of remission in non-life-threatening anti-neutrophil cytoplasmic antibodies associated vasculitis because of its strong immunosuppressive potency and low toxicity profile. Enteric-coated mycophenolate sodium (EC-MPS) was introduced to reduce gastrointestinal adverse reactions of MMF. This study will evaluate the efficacy and safety of EC-MPS combined with glucocorticoid in patients with active and non-life-threatening microscopic polyangiitis (MPA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This study is a multicentre, open-label, randomised controlled, non-inferiority trial. A total of 110 patients with active and non-life-threatening MPA from 11 hospitals in Shanxi Province of China will be recruited and randomised in a 1:1 ratio to receive either EC-MPS or CYC. All patients will receive the same glucocorticoid plan. We will compare oral EC-MPS (720\u20131440\u2009mg\/day) with intravenous pulsed CYC (7.5\u201315\u2009mg\/kg) administered for 3\u20136 months. All patients will be switched from their assigned treatment (EC-MPS or CYC) to oral azathioprine (2\u2009mg\/kg\/day) after remission has been achieved, between 3 and 6 months. Azathioprine will be continued until the study ends at 18 months. The primary end point of efficacy is the remission rate at 6 months. Follow-up will continue for 18 months in order to detect an influence of induction regimen on subsequent relapse rates.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study has received approval from the Ethics Committee of the Second Hospital of Shanxi Medical University (2022YX-026). All participants are required to provide written informed consent and no study-related procedures will be performed until consent is obtained. The results of this trial will be published in peer-reviewed journals and presented at conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ChiCTR2200063823.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-074662","type":"journal-article","created":{"date-parts":[[2024,3,12]],"date-time":"2024-03-12T02:40:33Z","timestamp":1710211233000},"page":"e074662","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Enteric-coated Mycophenolate Sodium therApy versus cyclophosphamide for induction of Remission in Microscopic PolyAngiitis (EMSAR-MPA trial): study protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"14","author":[{"given":"Sijia","family":"Li","sequence":"first","affiliation":[{"name":"Division of Nephrology, Shanxi Medical University Second 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