Study protocol for a phase III multicentre, randomised, open-label, blinded-end point trial to evaluate the efficacy and safety of immunoglobulin plus cyclosporin A in patients with severe Kawasaki disease (KAICA Trial).
Reiko Aoyagi,Hiromichi Hamada,Yasunori Sato,Hiroyuki Suzuki,Yoshihiro Onouchi,Ryota Ebata,Kengo Nagashima,Moe Terauchi,Masaru Terai,Hideki Hanaoka,Akira Hata +10 more
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TLDR
This trial compares the current standard therapy of intravenous immunoglobulin (IVIG) and the combined IVIG+CsA therapy in paediatric patients with severe KD and hypothesise that cyclosporin A (CsA) may be effective in treating KD by regulating the Ca2+/NFAT signalling pathway.Abstract:
Introduction Kawasaki disease (KD) is an acute, self-limited vasculitis of unknown aetiology that predominantly affects infants and young children. We hypothesise that cyclosporin A (CsA) may be effective in treating KD by regulating the Ca 2+ /NFAT signalling pathway. This trial compares the current standard therapy of intravenous immunoglobulin (IVIG) and the combined IVIG+CsA therapy in paediatric patients with severe KD. Methods and analysis This trial is a phase III, multicentre, randomised, open-label, blinded-end point trial that evaluates the efficacy and safety of IVIG+CsA therapy. Patients with severe KD who satisfy the eligibility criteria are randomised (1:1) to receive either CsA (5 mg/kg/day for 5 days; Neoral) plus high-dose IVIG (2 g/kg for 24 h and aspirin 30 mg/kg/day), or high-dose IVIG alone (2 g/kg for 24 h and aspirin 30 mg/kg/day). The primary end point is the frequency of occurrence of coronary artery abnormalities during the trial period. An independent end point review committee will be in charge of the trial assessment. Ethics and dissemination The protocol was approved by the Institutional Review Board of each institution. The trial was notified and registered at the Pharmaceutical and Medical Devices Agency, in Japan. The trial is currently on-going and is scheduled to finish in April 2017. The findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number JMA-IIA00174; Pre-results.read more
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JCS/JSCS 2020 Guideline on Diagnosis and Management of Cardiovascular Sequelae in Kawasaki Disease
Ryuji Fukazawa,Junjiro Kobayashi,Mamoru Ayusawa,Hiromichi Hamada,Masaru Miura,Yoshihide Mitani,Etsuko Tsuda,Hiroyuki Nakajima,Hiroyuki Matsuura,Kazuyuki Ikeda,Kazuhiko Nishigaki,Hiroyuki Suzuki,Kei Takahashi,Kenji Suda,Hiroshi Kamiyama,Yoshihiro Onouchi,Tohru Kobayashi,Hiroyoshi Yokoi,Kisaburo Sakamoto,Masami Ochi,Soichiro Kitamura,Kenji Hamaoka,Hideaki Senzaki,Takeshi Kimura +23 more
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Efficacy of primary treatment with immunoglobulin plus ciclosporin for prevention of coronary artery abnormalities in patients with Kawasaki disease predicted to be at increased risk of non-response to intravenous immunoglobulin (KAICA): a randomised controlled, open-label, blinded-endpoints, phase 3 trial
Hiromichi Hamada,Hiroyuki Suzuki,Yoshihiro Onouchi,Ryota Ebata,Masaru Terai,Shigeto Fuse,Yoshitomo Okajima,Shunji Kurotobi,Katsuki Hirai,Takashi Soga,Yukiko Ishiguchi,Yoshiaki Okuma,Nobuyuki Takada,Masaaki Yanai,Junichi Sato,Mami Nakayashiro,Mamoru Ayusawa,Eiichi Yamamoto,Yuichi Nomura,Yuya Hashimura,Kazunobu Ouchi,Hiroshi Masuda,Shinichi Takatsuki,Keiichi Hirono,Tadashi Ariga,Takashi Higaki,Akio Otsuki,Moe Terauchi,Reiko Aoyagi,Takatoshi Sato,Yasuhisa Fujii,Tadami Fujiwara,Hideki Hanaoka,Akira Hata,Takafumi Honda,Kumi Yasukawa,Nishihara Takahiro,Hideoki Yajima,Hideyasu Ooto,You Umeda,Takashi Takeuchi,Tomohiro Suenaga,Nobuyuki Kakimoto,Masahiro Kamada,Shinichi Suwabe,Yasushi Ueno,Natsuko Nishi,Yuuko Saito,Yutaka Kitani,Taisuke Nabeshima,Kiyotaka Takefuta,Takahiro Nakamura,Akiko Komori,Masataka Kato,Naoki Saito,Kentaro Okunushi,Hironobu Kobayashi,Takeshi Nakano,Kiminori Masuda,Hirotaka Minami,Takamichi Uchiyama,You Okizuka,Naoki Ohno,Satoko Ogita,Hiroshi Ono,Akira Ishiguro,Tsutomu Saji,Fukiko Ichida,Sayaka Ozawa,Atsuhito Takeda,Gaku Izumi,Michiko Hanawa +71 more
TL;DR: Combined primary therapy with IVIG and ciclosporin was safe and effective for favourable coronary artery outcomes in Kawasaki disease patients who were predicted to be unresponsive to IVIG.
Journal ArticleDOI
Kawasaki disease: etiopathogenesis and novel treatment strategies
TL;DR: Though self-limiting in many cases, Kawasaki disease can lead to severe complications like coronary artery aneurysms and thrombo-embolic occlusions, and hence requires early diagnosis and urgent attention to avoid them.
Journal ArticleDOI
The genetics of Kawasaki disease
TL;DR: Kawasaki disease is a complex disorder which affects genetically susceptible infants and children and knowledge of susceptibility genes involved in the pathogenesis of KD may provide new insights into diagnosis and treatment of this condition.
Journal ArticleDOI
Genetic Variation in the SLC8A1 Calcium Signaling Pathway Is Associated With Susceptibility to Kawasaki Disease and Coronary Artery Abnormalities.
Chisato Shimizu,Hariklia Eleftherohorinou,Victoria J. Wright,Jihoon Kim,Martin P. Alphonse,James C. Perry,Rolando Cimaz,David Burgner,Nagib Dahdah,Long T. Hoang,Chiea Chuen Khor,Andrea Salgado,Adriana H. Tremoulet,Sonia Davila,Taco W. Kuijpers,Martin L. Hibberd,Todd A. Johnson,Atsushi Takahashi,Tatsuhiko Tsunoda,Michiaki Kubo,Toshihiro Tanaka,Yoshihiro Onouchi,Rae S. M. Yeung,Lachlan J. M. Coin,Michael Levin,Jane C. Burns +25 more
TL;DR: The role of SLC8A1 polymorphisms in altering calcium flux in cells that mediate coronary artery damage in KD suggests that this pathway may be a therapeutic target and supports the study of calcineurin inhibitors in acute KD.
References
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Categorical Data Analysis
TL;DR: In this article, categorical data analysis was used for categorical classification of categorical categorical datasets.Categorical Data Analysis, categorical Data analysis, CDA, CPDA, CDSA
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TL;DR: Categorical data analysis, Categorical Data Analysis (CDA) as discussed by the authors, کتابخانه الکرونیک و دیجیتال - آذرسا
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Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial.
TL;DR: A new general procedure for treatment assignment is described which concentrates on minimizing imbalance in the distributions of treatment numbers within the levels of each individual prognostic factor.
Journal ArticleDOI
Diagnosis, Treatment, and Long-Term Management of Kawasaki Disease A Statement for Health Professionals From the Committee on Rheumatic Fever, Endocarditis and Kawasaki Disease, Council on Cardiovascular Disease in the Young, American Heart Association
Jane W. Newburger,Masato Takahashi,Michael A. Gerber,Michael H. Gewitz,Lloyd Y. Tani,Jane C. Burns,Stanford T. Shulman,Ann F. Bolger,Patricia Ferrieri,Robert S. Baltimore,Walter R. Wilson,Larry M. Baddour,Matthew E. Levison,Thomas J. Pallasch,Donald A. Falace,Kathryn A. Taubert +15 more
TL;DR: Recommendations for the initial evaluation, treatment in the acute phase, and long-term management of patients with Kawasaki disease are intended to assist physicians in understanding the range of acceptable approaches for caring for patients withawasaki disease.
Journal ArticleDOI
Diagnosis, treatment, and long-term management of Kawasaki disease: A statement for health professionals from the committee on rheumatic fever, endocarditis, and Kawasaki disease, council on cardiovascular disease in the young, American Heart Association
Jane W. Newburger,Masato Takahashi,Michael A. Gerber,Michael H. Gewitz,Lloyd Y. Tani,Jane C. Burns,Stanford T. Shulman,Ann F. Bolger,Patricia Ferrieri,Robert S. Baltimore,Walter R. Wilson,Larry M. Baddour,Matthew E. Levison,Thomas J. Pallasch,Donald A. Falace,Kathryn A. Taubert +15 more
TL;DR: A new algorithm is proposed to aid clinicians in deciding which children with fever for ≥5 days and ≤4 classic criteria should undergo electrocardiography, receive intravenous gamma globulin (IVIG) treatment, or both for Kawasaki disease.
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