International Collaborative Sutudy for Surrogate Renal Outcomes in Clinical Research

• Project/Area Number: 15H05291
• Research Category: Grant-in-Aid for Scientific Research (B)
• Allocation Type: Single-year Grants
• Section: 海外学術
• Research Field: Kidney internal medicine
• Research Institution: Nagoya University
• Principal Investigator: Yasuda Yoshinari 名古屋大学, 医学系研究科, 寄附講座准教授 (60432259)
• Co-Investigator(Kenkyū-buntansha): 丸山 彰一 名古屋大学, 医学系研究科, 教授 (10362253) ; 堀尾 勝 大阪大学, 医学系研究科, 准教授 (20273633) ; 石井 秀樹 名古屋大学, 医学部附属病院, 講師 (90456674)
• Research Collaborator: ISEKI kunitoshi
• Project Period (FY): 2015-04-01 – 2018-03-31
• Project Status: Completed (Fiscal Year 2018)
• Budget Amount: ¥12,610,000 (Direct Cost: ¥9,700,000、Indirect Cost: ¥2,910,000); Fiscal Year 2017: ¥4,160,000 (Direct Cost: ¥3,200,000、Indirect Cost: ¥960,000); Fiscal Year 2016: ¥3,900,000 (Direct Cost: ¥3,000,000、Indirect Cost: ¥900,000); Fiscal Year 2015: ¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
• Keywords: 腎代替アウトカム指標 / GFR / 尿タンパク / IgA腎症 / GFR推算式 / 腎アウトカム指標 / 血清クレアチニン / 血清シスタチンC / GFR低下速度 / 内科 / 臨床 / 循環器・高血圧 / 血清クレアチニン値 / 血清シスタチンC値 / 尿蛋白 / 糖尿病

Outline of Final Research Achievements

In Asian collaborative study, we analyzed suitable surrogate renal outcomes for clinical research. First, we established accurate renal function evaluation methods for Korean, Taiwan ,Thai and Indian CKD patients. Second, we analyzed utility of various renal outcomes in Asia. In health-check subject and CKD cohort studies, 30% decrease in eGFR could be surrogate renal outcome instead of hard end point including end stage kidney disease. Among IgA nephropathy patients, 50% increase in serum creatinine was good renal outcome to assess treatment effect and prognosis in renal biopsy. By surveillance of Asian renal outcome studies, GFR decline rate was sensitive and reliable renal outcome.

Academic Significance and Societal Importance of the Research Achievements

アジア人種に適した腎機能評価法に基づく腎代替アウトカム指標を用いることで、腎領域における臨床研究が推進できると期待される。本研究を通じたアジア各国との国際共同体制は、日本を中心とした腎領域国際共同研究の基盤となる。

Research Products

• [Int'l Joint Research] Seoul National University(韓国)
• [Int'l Joint Research] Postgratitude Institute/George Institute(インド)
• [Int'l Joint Research] Seoul National University(韓国)
• [Int'l Joint Research] National Taiwan University/Kaoshiung Medical University(Taiwan)
• [Int'l Joint Research] Jhons Hopkins University/Michigan University(米国)
• [Int'l Joint Research] King Chulaklongkorn Memorial Hospital(Thailand)
• [Int'l Joint Research] Postgratitude Institute/George Institute(India)
• [Int'l Joint Research] Johns Hopkins大学/Michigan大学(米国)
• [Int'l Joint Research] Taiwan National University/Kaohsiung Medical University(Taiwan)
• [Int'l Joint Research] Seoul National University/Yonsei University(韓国)
• [Int'l Joint Research] Postgraduate Institute/George Institute(India)
• [Int'l Joint Research] King Chulalongkorn Memorial Hospital(Thailand)
• [Journal Article] Tonsillectomy in IgA Nephropathy: A Nationwide Cohort Study in Japan (2019)
  • Author(s): Keita Hirano, Keichi Matsuzaki, Takashi Yasuda, Masako Nishikawa, Yoshinari Yasuda, Kentaro Koike, Shoichi Maruyama, Takashi Yokoo, Seiichi Matsuo, Tetsuya Kawamura, and Yusuke Suzuki
  • Journal Title: JAMA Network Open Volume: －
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Clinical impact of endocapillary proliferation with modified cutoff points in IgA nephropathy patients. (2019)
  • Author(s): Kaihan AB, Yasuda Y, Imaizumi T, Inagaki K, Ozeki T, Hishida M, Katsuno T, Tsuboi N, Maruyama S
  • Journal Title: PLoS One Volume: 14 Issue: 3 Pages: e0214414-e0214414
  • DOI: 10.1371/journal.pone.0214414
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Clinical impact of endocapillary proliferation according to the Oxford classification among adults with Henoch-Schönlein purpura nephritis: a multicenter retrospective cohort study. (2018)
  • Author(s): Inagaki K, Kaihan AB, Hachiya A, Ozeki T, Ando M, Kato S, Yasuda Y, Maruyama S.
  • Journal Title: BMC Nephrol. Volume: 19 Issue: 1 Pages: 208-208
  • DOI: 10.1186/s12882-018-1009-z
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Existing creatinine-based equations overestimate glomerular filtration rate in Indians (2018)
  • Author(s): Kumar V, Yadav AK, Yasuda Y, Horio M, Kumar V, Sahni N, Gupta KL, Matsuo S, Kohli HS, Jha V
  • Journal Title: BMC Nephrol. Volume: 19 Issue: 1 Pages: 22-22
  • DOI: 10.1186/s12882-018-0813-9
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Trace proteinuria by dipstick screening is associated with metabolic syndrome, hypertension, and diabetes. (2018)
  • Author(s): Okada R, Yasuda Y, Tsushita K, Wakai K, Hamajima N, Matsuo S.
  • Journal Title: Clin Exp Nephrol. Volume: 22 Issue: 6 Pages: 1387-1394
  • DOI: 10.1007/s10157-018-1601-3
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] Seasonal proteinuria changes in IgA nephropathy patients after proteinuria remission. (2017)
  • Author(s): Inagaki K, Yasuda Y, Ando M, Kaihan AB, Hachiya A, Ozeki T, Hishida M, Imaizumi T, Katsuno T, Kato S, Tsuboi N, Maruyama S
  • Journal Title: PLoS One, Volume: 12 Issue: 11 Pages: e0187607-e0187607
  • DOI: 10.1371/journal.pone.0187607
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] The Japanese Histologic Classification and T-score in the Oxford Classification system could predict renal outcome in Japanese IgA nephropathy patients. (2017)
  • Author(s): Kaihan AB, Yasuda Y, Katsuno T, Kato S, Imaizumi T, Ozeki T, Hishida M, Nagata T, Ando M, Tsuboi N, Maruyama S.
  • Journal Title: Clin Exp Nephrol. Volume: 21 Issue: 6 Pages: 986-994
  • DOI: 10.1007/s10157-017-1393-x
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] Urinary and circulating levels of the anti-angiogenic isoform of vascular endothelial growth factor-A in patients with chronic kidney disease. (2017)
  • Author(s): Kikuchi R, Yasuda Y, Nakatochi M, Shibata Y, Hara T, Suzuki A, Imaizumi T, Suzuki S, Ishii H, Takeshita K, Matsushita T, Maruyama S, Murohara T.
  • Journal Title: Clin Chim Acta. Volume: 475 Pages: 102-108
  • DOI: 10.1016/j.cca.2017.10.014
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] Impact of Skeletal Muscle Mass on Long-Term Adverse Cardiovascular Outcomes in Patients With Chronic Kidney Disease. (2017)
  • Author(s): Harada K, Suzuki S, Ishii H, Aoki T, Hirayama K, Shibata Y, Negishi Y, Sumi T, Kawashima K, Kunimura A, Shimbo Y, Tatami Y, Kawamiya T, Yamamoto D, Morimoto R, Yasuda Y, Murohara T.
  • Journal Title: Am J Cardiol. Volume: 119 Pages: 1275-1280
• [Journal Article] Obvious Pitfall in the Estimation of Renal Dysfunction. (2016)
  • Author(s): Shimokata T, Yasuda Y, Ando Y.
  • Journal Title: J Clin Oncol. Volume: 34 Pages: 2429-2429
• [Journal Article] Evidence-based clinical practice guidelines for IgA nephropathy 2014. (2016)
  • Author(s): Yuzawa Y, Yamamoto R, Takahashi K, Katafuchi R, Tomita M, Fujigaki Y, Kitamura H, Goto M, Yasuda T, Sato M, Urushihara M, Kondo S, Kagami S, Yasuda Y, Komatsu H, Takahara M, Harabuchi Y, Kimura K, Matsuo S.
  • Journal Title: Clin Exp Nephrol. Volume: 20 Issue: 4 Pages: 511-35
  • DOI: 10.1007/s10157-015-1223-y
  • Peer Reviewed / Open Access
• [Journal Article] Upper-normal waist circumference is a risk marker for metabolic syndrome in normal-weight subjects. (2016)
  • Author(s): Okada R, Yasuda Y, Tsushita K, Wakai K, Hamajima N, Matsuo S.
  • Journal Title: Nutr Metab Cardiovasc Dis. Volume: 26 Issue: 1 Pages: 67-76
  • DOI: 10.1016/j.numecd.2015.10.001
• [Journal Article] Impact of noninvasive cardiovascular screening programs as a predictor of cardiovascular events among asymptomatic chronic kidney disease patients. (2016)
  • Author(s): Sawai A, Yasuda Y, Suzuki S, Ishii H, Goto M, Kato S, Hayashi M, Maruyama S, Murohara T, Oiso Y and Matsuo S.
  • Journal Title: Clin Exp Nephrol, Volume: 20 Issue: 3 Pages: 416-24
  • DOI: 10.1007/s10157-015-1169-0
• [Journal Article] The effectiveness and safety of modest exercise in Japanese patients with chronic kidney disease: a single-armed interventional study. (2016)
  • Author(s): Hamada M, Yasuda Y, Kato S, Arafuka H, Goto M, Hayashi M, Kajita E, Maruyama S.
  • Journal Title: Clin Exp Nephrol Volume: 20 Issue: 2 Pages: 204-11
  • DOI: 10.1007/s10157-015-1147-6
  • NAID: 120005844132
• [Journal Article] Association of Estimated Glomerular Filtration Rate and Proteinuria With Lipid-Rich Plaque in Coronary Artery Disease (2015)
  • Author(s): Shimbo Y, Suzuki S, Ishii H, Shibata Y, Tatami Y, Harata S, Osugi N, Ota T, Tanaka T, Shibata K, Mizukoshi T, Yasuda Y, Maruyama S, Murohara T.
  • Journal Title: Circulation Journal Volume: 79 Issue: 10 Pages: 2263-2270
  • DOI: 10.1253/circj.CJ-15-0460
  • NAID: 130005099864
  • ISSN: 1346-9843, 1347-4820
• [Journal Article] Is the new GFR equation using inulin clearance a more accurate method for Asian patients? (2015)
  • Author(s): Kim BS, Lee YK, Choi HY, Choi SO, Shin SK, Ha SK, Lee KW, Kim YW, Kim YL, Yasuda Y, Imai E, Horio M, Tomino Y, Matsuo S, Lee HY.
  • Journal Title: Clin Nephrol. Volume: 84 Issue: 12 Pages: 331-8
  • DOI: 10.5414/cn108496
  • Peer Reviewed
• [Journal Article] Impact of abdominal aortic calcification on long-term cardiovascular outcomes in patients with chronic kidney disease. (2015)
  • Author(s): Tatami Y, Yasuda Y, Suzuki S, Ishii H, Sawai A, Shibata Y, Ota T, Shibata K, Niwa M, Morimoto R, Hayashi M, Kato S, Maruyama S, Murohara T.
  • Journal Title: Atherosclerosis. Volume: 243 Issue: 2 Pages: 349-55
  • DOI: 10.1016/j.atherosclerosis.2015.10.016
• [Journal Article] Renal function evaluation in patients with cancer who were scheduled to receive carboplatin or S-1. (2015)
  • Author(s): Shibata K, Yasuda Y, Kobayashi R, Ando Y, Shimokata T, Kamiya H, Hayashi M, Maruyama S, Matsuo S, Nakao M, Tsuchiya T, Teramachi H.
  • Journal Title: Clin Exp Nephrol Volume: 19 Issue: 6 Pages: 1107-13
  • DOI: 10.1007/s10157-015-1115-1
  • Peer Reviewed
• [Journal Article] Effects of serum albumin and glycated albumin levels on performance of the Japanese GFR equation based on serum cystatin C. (2015)
  • Author(s): Horio M, Imai E, Yasuda Y, Watanabe T, Yokoyama H, Makino H, Matsuo S.
  • Journal Title: Clin Exp Nephrol Volume: inpress Issue: 4 Pages: 626-30
  • DOI: 10.1007/s10157-014-1038-2
  • Peer Reviewed
• [Journal Article] Extension of the Calvert formula to patients with severe renal insufficiency. (2015)
  • Author(s): Oguri, Tomoyo; Tomoya, Shimokata; Ito, Isao; Yasuda, Yoshinari; Sassa, Naoto; Nishiyama, Masami; Hamada, Akinobu; Hasegawa, Yoshinori; Ando, Yuichi.
  • Journal Title: Cancer Chemotherapy and Pharmacology Volume: 76 Issue: 1 Pages: 53-9
  • DOI: 10.1007/s00280-015-2769-9
• [Journal Article] Longitudinal study of the decline in renal function in healthy subjects (2015)
  • Author(s): 1.Baba M, Shimbo T, Horio M, Ando M, Yasuda Y, Komatsu Y, Masuda K, Matsuo S, and Maruyama S
  • Journal Title: PLoS One Volume: 10 Issue: 6 Pages: e0129036-e0129036
  • DOI: 10.1371/journal.pone.0129036
  • Peer Reviewed
• [Journal Article] Clinical Impact of Kidney Function on Presepsin Levels (2015)
  • Author(s): 1.Nagata T, Yasuda Y, Ando M, Abe T, Katsuno T, Kato S, Tsuboi N, Matsuo S, and Maruyama S
  • Journal Title: PLoS One Volume: 10 Issue: 6 Pages: e0129159-e0129159
  • DOI: 10.1371/journal.pone.0129159
  • Peer Reviewed
• [Presentation] 酵素法による血清インドキシル硫酸（IS）測定の意義：ISはCKD患者の腎機能低下に関連する (2019)
  • Author(s): 安田 宜成、菊地 良介、Kaihan Ahmad Baseer、今井 順子、柴田 典子、丹羽 操、後藤 千慶、倉沢 史門、岡崎 雅樹、板野 祐也、蜂矢 朝香、稲垣 浩司、菊池 京子、尾関 貴哉、斎藤 尚二、鈴木 康弘、加藤 規利、石本 卓嗣、小杉 智規、加藤 佐和子、水野 正司、丸山 彰一
  • Organizer: 第3回日本Uremic Toxin研究会学術集
• [Presentation] 酵素法による血清インドキシル硫酸（IS）測定の意義：横断分析によるIS関連因子 (2019)
  • Author(s): 安田 宜成、菊地 良介、Kaihan Ahmad Baseer、今井 順子、柴田 典子、丹羽 操、後藤 千慶、倉沢 史門、岡崎 雅樹、板野 祐也、蜂矢 朝香、稲垣 浩司、菊池 京子、尾関 貴哉、斎藤 尚二、鈴木 康弘、加藤 規利、石本 卓嗣、小杉 智規、加藤 佐和子、水野 正司、丸山 彰一
  • Organizer: 第3回日本Uremic Toxin研究会学術集
• [Presentation] Clinical impact of modified MESC Classification for renal outcome among Japanese IgAN patients (2018)
  • Author(s): Yoshinari Yasuda
  • Organizer: The 16thAsia Pacific Congress of Nephrology
  • Int'l Joint Research
• [Presentation] KDIGO生体腎移植ドナーガイドライン(案）腎機能評価法の検証 (2016)
  • Author(s): 安田宜成, 今井順子, 勝野敬之, 丸山彰一
  • Organizer: 第59回日本腎臓学会学術総会
  • Place of Presentation: パシフィコ横浜（神奈川県横浜市）
  • Year and Date: 2016-06-17
• [Presentation] イヌリンクリアランス簡易法の実測GFRによるGFR推算式の検証 (2016)
  • Author(s): 今井順子, 安田宜成, 柴田佳菜子, 松本祐之, 丹羽操, 丸山彰一
  • Organizer: 第59回日本腎臓学会学術総会
  • Place of Presentation: パシフィコ横浜（神奈川県横浜市）
  • Year and Date: 2016-06-17
• [Presentation] eGFR自動レポートの慢性関節リウマチ患者へのメトトレキサート処方への影響 (2016)
  • Author(s): 柴田佳菜子, 安田宜成, 舟橋康治, 小嶋 俊久, 丸山彰一
  • Organizer: 第59回日本腎臓学会学術総会
  • Place of Presentation: パシフィコ横浜（神奈川県横浜市）
  • Year and Date: 2016-06-17
• [Presentation] IgA腎症の寛解が予後に与える影響 ～後方視的多施設コホート研究における検証～ (2016)
  • Author(s): 松崎慶一, 鈴木祐介, 鈴木仁, 川村哲也, 堀越哲, 富野康日己, 安田宜成, 安田隆, 松尾清一
  • Organizer: 第59回日本腎臓学会学術総会
  • Place of Presentation: パシフィコ横浜（神奈川県横浜市）
  • Year and Date: 2016-06-17
• [Presentation] IgA腎症に対する扁摘パルス・パルス単独療法におけるプロトコールの違いが予後に与える影響 (2016)
  • Author(s): 森山能仁, 片岡浩, 内田啓子, 安田隆, 安田宜成, 川村哲也, 松尾清一, 新田孝作
  • Organizer: 第59回日本腎臓学会学術総会
  • Place of Presentation: パシフィコ横浜（神奈川県横浜市）
  • Year and Date: 2016-06-17
• [Presentation] ステロイド治療後に蛋白尿寛解に至るも血尿が残存したIgA腎症患者の腎予後の検討 (2016)
  • Author(s): 白井小百合, 市川大介, 柴垣有吾, 安田宜成, 安田隆, 川村哲也
  • Organizer: 第59回日本腎臓学会学術総会
  • Place of Presentation: パシフィコ横浜（神奈川県横浜市）
  • Year and Date: 2016-06-17
• [Presentation] 人間ドック受診者における血清シスタチンC検査の意義 (2016)
  • Author(s): 丹羽操, 安田宜成, 今井順子, 柘植和子, 大橋功男, 伊藤和幸, 丸山彰一
  • Organizer: 第59回日本腎臓学会学術総会
  • Place of Presentation: パシフィコ横浜（神奈川県横浜市）
  • Year and Date: 2016-06-17
• [Presentation] 人間ドック受診者におけるアルブミン尿検査の意義 (2016)
  • Author(s): 丹羽操, 安田宜成, 今井順子, 柴田佳菜子, 伊藤和幸, 丸山彰一
  • Organizer: 第59回日本腎臓学会学術総会
  • Place of Presentation: パシフィコ横浜（神奈川県横浜市）
  • Year and Date: 2016-06-17
• [Presentation] 成人微小変化型ネフローゼ症候群の再発時のステロイド投与量についての検討 (2016)
  • Author(s): 尾関貴哉, 勝野敬之, 加藤佐和子, 安田宜成, 松尾清一, 丸山彰一
  • Organizer: 第59回日本腎臓学会学術総会
  • Place of Presentation: パシフィコ横浜（神奈川県横浜市）
  • Year and Date: 2016-06-17
• [Presentation] IgA腎症の治療介入1年後の尿蛋白量はどのように腎予後と関連するか (2016)
  • Author(s): 平野景太, 川村哲也, 隅山昌洋, 小池健太郎, 清水昭博, 坪井伸夫, 宮崎陽一, 小倉誠, 安田宜成, 安田隆, 丸山彰一, 松尾清一, 横尾隆
  • Organizer: 第59回日本腎臓学会学術総会
  • Place of Presentation: パシフィコ横浜（神奈川県横浜市）
  • Year and Date: 2016-06-17
• [Presentation] IgA腎症に対する肥満と脂質異常症の影響について (2016)
  • Author(s): 有安由紀, 鳥越和雄, 垣田浩子, 遠藤知美, 鈴木洋行, 米本智美, 安田隆, 安田宜成, 武曾惠理
  • Organizer: 第59回日本腎臓学会学術総会
  • Place of Presentation: パシフィコ横浜（神奈川県横浜市）
  • Year and Date: 2016-06-17
• [Presentation] KDIGO生体腎移植ドナーガイドライン案の検証 (2016)
  • Author(s): 安田宜成, 今井順子, 勝野敬之, 丸山彰一
  • Organizer: 第61回日本透析医学会学術集会・総会
  • Place of Presentation: 大阪国際会議場（大阪府大阪市）
  • Year and Date: 2016-06-09
• [Presentation] The Microalbminuria Intervention Study: Effects of Different Losartan Combination Antihypertensive Therapy in Patients with CKD, MIDLANDCKD. (2015)
  • Author(s): Yoshinari Yasuda, Takeyuki Hiramatsu, Seiichi Matsuo, Shoichi Maruyama.
  • Organizer: American Society of Nephrology Kidney Week
  • Place of Presentation: San Diego, CA（USA）
  • Year and Date: 2015-11-03
• [Presentation] Effects of Tonsillectomy Combined with Steroid Pulse Therapy upon IgA Nephropathy Depending on Proteinuria Status at Diagnosis. (2015)
  • Author(s): Hiroyuki Komatsu, Shouichi Fujimoto, Yuji Sato, Akihiro Fukuda, Yoshinari Yasuda, Takashi Yasuda, Tetsuya Kawamura, Seiichi Matsuo.
  • Organizer: American Society of Nephrology Kidney Week
  • Place of Presentation: San Diego, CA（USA）
  • Year and Date: 2015-11-03
• [Presentation] Evaluation of KDIGO Clinical Practice Guidelines for IgA Nephropathy by Japanese Multicenter Large Cohort Study. (2015)
  • Author(s): Kyoko Watanabe, Kentaro Koike, Akihiro Shimizu, Nobuo Tsuboi, Keita Hirano, Makoto Ogura, Sayuri Shirai, Yoshinari Yasuda, Takashi Yasuda, Shoichi Maruyama, Tetsuya Kawamura, Seiichi Matsuo, Takashi Yokoo.
  • Organizer: American Society of Nephrology Kidney Week
  • Place of Presentation: San Diego, CA（USA）
  • Year and Date: 2015-11-03
• [Presentation] 慢性腎臓病患者における腹部大動脈および冠動脈石灰化との関係 (2015)
  • Author(s): 鈴木進, 澤井昭宏, 丹羽操, 柴田佳菜子, 安田宜成, 加藤佐和子, 丸山彰一, 松尾清一
  • Organizer: 第58回日本腎臓学会学術総会
  • Place of Presentation: 名古屋国際会議場(愛知県名古屋市）
  • Year and Date: 2015-06-05
• [Presentation] 坦癌患者においてシスタチンCは腎機能を過小評価する (2015)
  • Author(s): 柴田佳菜子, 安田宜成, 鈴木進, 下方智也, 丸山彰一, 安藤雄一, 松尾清一
  • Organizer: 第58回日本腎臓学会学術総会
  • Place of Presentation: 名古屋国際会議場(愛知県名古屋市）
  • Year and Date: 2015-06-05
• [Presentation] プレセプシン値に与える腎機能の影響 (2015)
  • Author(s): 永田高信, 安田宜成, 阿部智子, 勝野敬之, 加藤佐和子, 坪井直毅, 松尾清一, 丸山彰一
  • Organizer: 第58回日本腎臓学会学術総会
  • Place of Presentation: 名古屋国際会議場(愛知県名古屋市）
  • Year and Date: 2015-06-05
• [Funded Workshop] The 8th CKD Frontier Meeting (2019)
• [Funded Workshop] The 7th CKD Frontier Meeting (2018)
• [Funded Workshop] The 6th CKD Frontier Meeting (2017)
  • Place of Presentation: キャッスルプラザ（愛知県名古屋市）
  • Year and Date: 2017-02-25