タナカ　リョウジロウ   Ryojiro Tanaka   田中　亮二郎    所属   川崎医科大学  医学部 臨床医学　小児科学    職種   特任教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Cyclosporine C2 monitoring for the treatment of frequently relapsing nephrotic syndrome in children: a multicenter randomized phase II trial.
掲載誌名	正式名：Clinical journal of the American Society of Nephrology : CJASN 略　 称：Clin J Am Soc Nephrol ISSNコード：1555905X/15559041
掲載区分	国外
巻・号・頁	9(2),pp.271-8
著者・共著者	Kazumoto Iijima, Mayumi Sako, Mari Saito Oba, Shuichi Ito, Hiroshi Hataya, Ryojiro Tanaka, Yoko Ohwada, Koichi Kamei, Kenji Ishikura, Nahoko Yata, Kandai Nozu, Masataka Honda, Hidefumi Nakamura, Michio Nagata, Yasuo Ohashi, Koichi Nakanishi, Norishige Yoshikawa,
発行年月	2014/02
概要	BACKGROUND AND OBJECTIVES:An open-label, multicenter, randomized phase II trial was conducted from July 1, 2005 to March 29, 2011 to compare two protocols for treating children with frequently relapsing nephrotic syndrome using microemulsified cyclosporine.DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:Ninety-three children with frequently relapsing nephrotic syndrome were randomly assigned to group A (n=46) or group B (n=47). In both groups, the 2-hour postdose cyclosporine level was monitored. For group A, the cyclosporine target was set to 600-700 ng/ml for the first 6 months and 450-550 ng/ml for the next 18 months; for group B, it was set to 450-550 ng/ml for the first 6 months and 300-400 ng/ml for the next 18 months. The primary end point was the sustained remission rate. At the end of the study, if there was no difference in safety profile between the two groups and the sustained remission rate in group A was superior to group B with a decision threshold of 8%, then the regimen for group A would be determined the better treatment.RESULTS:Eight children from an ineligible institution, where cyclosporine levels were not measured, were excluded from all analyses. At 24 months, the sustained remission rate was nonsignificantly higher in group A (n=43) than group B (n=42; 64.4% versus 50.0%; hazard ratio, 0.57; 95% confidence interval, 0.29 to 1.11; P=0.09), and the progression-free survival rate was significantly higher (88.1% versus 68.4%; hazard ratio, 0.33; 95% confidence interval, 0.12 to 0.94; P=0.03). The relapse rate was significantly lower in group A than group B (0.41 versus 0.95 times/person-year; hazard ratio, 0.43; 95% confidence interval, 0.19 to 0.84; P=0.02). The rate and severity of adverse events were similar in both treatment groups.CONCLUSION:The sustained remission rate was not significantly different between the two treatment groups, but the regimen with the higher 2-hour postdose cyclosporine level target improved progression-free survival a
DOI	10.2215/CJN.13071212
PMID	24262503