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Rationale and design of the Japanese Biomarkers in Nephrotic Syndrome (J-MARINE) study

  • 期刊论文

  • 发表日期：

    2024年1月25日

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  • Shimon Kurasawa,
  • Sawako Kato,
  • Takaya Ozeki,
  • Shin’ichi Akiyama,
  • Takuji Ishimoto,
  • Masashi Mizuno,
  • Naotake Tsuboi,
  • Noritoshi Kato,
  • Tomoki Kosugi,
  • Shoichi Maruyama,
  • Hirofumi Tamai,
  • Asami Takeda,
  • Hibiki Shinjo,
  • Hanayo Arata,
  • Shoichi Maruyama,
  • Tomohiko Naruse,
  • Tomoharu Watanabe,
  • Keiju Hiromura,
  • Kei Fukami,
  • Naoki Nakagawa,
  • Toshiyuki Akahori,
  • Hideaki Shimizu,
  • Yoshiro Fujita,
  • Hideo Yasuda,
  • Naro Ohashi,
  • Yoshio Konishi,
  • Takashi Morikawa,
  • Kaoru Yasuda,
  • Yutaka Sugiyama,
  • Shinichiro Inaba,
  • Ichiei Narita,
  • Ryohei Kaseda,
  • Toshiyuki Imasawa,
  • Takehiko Kawaguchi,
  • Yukio Yuzawa,
  • Naotake Tsuboi,
  • Hiroki Hayashi,
  • Yusuke Suzuki,
  • Hitoshi Suzuki,
  • Yasuhiko Ito,
  • Takuji Ishimoto,
  • Takayuki Katsuno,
  • Shu Wakino,
  • Keiichi Tamagaki,
  • Chika Kondo,
  • Hisashi Kurata,
  • Takashi Wada,
  • Tatsuo Tsukamoto,
  • Kan Katayama,
  • Toshiki Tsuboi,
  • Makoto Mizutani,
  • Shouichi Fujimoto,
  • Tomoya Nishino,
  • Tsuneo Konta,
  • Kazunobu Ichikawa,
  • Hitoshi Yokoyama,
  • Yoshihide Fujigaki,
  • Masashi Mukoyama,
  • Takashige Kuwabara,
  • Hirotake Kasuga,
  • Satoshi Suzuki,
  • Hiroshi Kojima,
  • Masako Sakakibara,
  • Yoshitaka Isaka,
  • Ryohei Yamamoto,
  • Shinya Kaname,
  • Takahisa Kawakami,
  • Kojiro Nagai,
  • Shinji Furuta,
  • Hiroshi Sobajima,
  • Saori Tsukushi,
  • Akihito Yashima,
  • Hideto Oishi,
  • Mariko Miyazaki,
  • Akiyoshi Hirayama,
  • Hitoshi Sugiyama,
  • Yoshifumi Ubara,
  • Yugo Shibagaki,
  • Junichiro Kazama,
  • Saori Nishio,
  • Ichijiro Murata,
  • Toshiaki Nakano

摘要

Introduction

Disease subtyping and monitoring are essential for the management of nephrotic syndrome (NS). Although various biomarkers for NS have been reported, their clinical efficacy has not been comprehensively validated in adult Japanese patients.

Methods

The Japanese Biomarkers in Nephrotic Syndrome (J-MARINE) study is a nationwide, multicenter, and prospective cohort study in Japan, enrolling adult (≥18 years) patients with minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), membranous nephropathy (MN), membranoproliferative glomerulonephritis (MPGN), C3 glomerulopathy (C3G), and lupus nephritis (LN). Baseline clinical information and plasma and urine samples will be collected at the time of immunosuppressive therapy initiation or biopsy. Follow-up data and plasma and urine samples will be collected longitudinally based on the designated protocols. Candidate biomarkers will be measured: CD80, cytotoxic T-lymphocyte antigen 4, and soluble urokinase plasminogen activator receptor for MCD and FSGS; anti-phospholipase A2 receptor and thrombospondin type-1 domain-containing protein 7A antibodies for MN; fragment Ba, C3a, factor I, and properdin for MPGN/C3G; and CD11b, CD16b, and CD163 for LN. Outcomes include complete and partial remission, relapse of proteinuria, a 30% reduction in estimated glomerular filtration rate (eGFR), eGFR decline, and initiation of renal replacement therapy. The diagnostic accuracy and predictive ability for clinical outcomes will be assessed for each biomarker.

Results

From April 2019 to April 2023, 365 patients were enrolled: 145, 21, 138, 10, and 51 cases of MCD, FSGS, MN, MPGN/C3G, and LN, respectively.

Conclusion

This study will provide valuable insights into biomarkers for NS and serve as a biorepository for future studies.