A nationwide prospective cohort study of patients with advanced chronic kidney disease in Japan: The Reach-J CKD cohort study
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Epidemiology and outcomes of Japanese patients with advanced chronic kidney disease (CKD)—an estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73 m2—has remained largely unexamined.
We conducted a nationwide survey to determine the distribution of Japanese CKD patients, and are conducting a cohort study of these patients. A questionnaire eliciting details about facilities and their CKD practices was sent to all clinics/hospitals with nephrologists. Based on the survey results, we recruited 2400 advanced CKD patients receiving nephrologist care from at least 30 representative facilities throughout Japan, selected randomly with stratification by region and facility size. Through patient questionnaires and nephrologist-practice surveys aligned with the international CKD Outcomes and Practice Patterns Study (CKDopps), we shall annually or semi-annually collect patient, physician and clinic data prospectively, detailing CKD practices for 5 years, with a primary outcome of death or renal replacement therapy initiation, and secondary outcomes being decline of eGFR by 30% or 50%, CKD progression to CKD G5, or a cardiovascular event.
Of 790 eligible, responding facilities, 330 (41.8%) treat ≥80 advanced CKD patients in the average 3-month period. Regional distribution of these facilities is similar to that of persons in the general population. Hence, the 30 facilities selected for data collection appear to be geographically representative in Japan.
Our study will enhance understanding of various CKD practices and biological data associated with CKD progression, and allow international comparisons using the CKDopps platform. This will provide evidences to improve the health and quality of life for patients with advanced CKD.
KeywordsProspective cohort study Chronic kidney disease Practice pattern Reach-J CKDopps
We thank all the nephrology specialists in Japan who responded to our Reach-J survey, Dr. Hiroyuki Hoshimoto, Ms. Yukiko Ito and all the staff members of the Clinical Trial and Research Center, University of Tsukuba (T-CReDO), Mr. Yoshihiro Ishihara and other staff members of Flexible Inc., and Mr. Justin Albert, Mr. Brian Bieber, Mr. Doug Fuller, Ms. Christina Pustulka, and all the staff members of Arbor Research, for their contribution to our work.
The Reach-J CKD collaborators
Dr. Tomoya Hirayama, Kitasaito hospital, Hokkaido; Dr. Nobuhiko Togashi, JR Sapporo hospital, Hokkaido; Dr. Akira Sugiura, Osaki Citizen hospital, Miyagi; Dr. Kunihiro Yamagata, University of Tsukuba, Ibaraki; Dr. Tatsuo Shiigai, Shiigai clinic, Ibaraki; Dr. Kazue Ueki, Toho hospital, Gunma; Dr. Ken Kikkawa, Kikkawa Naika clinic, Saitama; Dr. Tsukasa Nakamura, Shinmatudo Central General Hospital, Chiba; Dr. Hideki Matsukuma, Funabashi Futawa hospital, Chiba; Dr. Shinsuke Harasawa, Nihon University hospital, Tokyo; Dr. Yuko Shibuya, NTT Medical Center Tokyo, Tokyo; Dr. Hitoshi Tagawa, Kichijoji Asahi Hospital; Dr. Shuzo Kobayashi, Shonan-Kamakura General Hospital, Kanagawa; Dr. Masaki Nagasawa, Shinonoi General Hospital, Nagano; Dr. Minako Wakasugi, Niigata University Hospital, Niigata; Dr. Hajime Yamazaki, Nagaoka Red Cross Hospital, Niigata; Dr. Michio Matsumoto, Toyama Saiseikai Toyama Hospital, Toyama; Dr. Shoichi Maruyama, Nagoya University Hospital, Aichi; Dr. Norihiro Suga, Nagoya City West Medical Center, Aichi; Dr. Keiichi Tamagaki, Kyoto Prefectural University of Medicine Hospital, Kyoto; Dr. Taiko Kimura, Nantan Hospital, Kyoto; Dr. Tsutomu Tabata, Inoue Hospital, Osaka; Dr. Shinichi Nishi, Kobe University Hospital, Hyogo; Dr. Yuriko Yonekura, Akashi Medical Center, Hyogo; Dr. Hitoshi Sugiyama, Okayama University Hospital, Okayama; Dr. Naoki Kashihara, Kawasaki Medical School Hospital, Okayama; Dr. Tadashi Sofue, Kagawa University hospital, Kagawa; Dr. Kazuhiko Tsuruya, Kyushu University Hospital, Fukuoka; Dr. Masato Tadokoro, Nagasaki Harbor Medical Center City Hospital, Nagasaki; Dr. Shoichi Fujimoto, University of Miyazaki Hospital, Miyazaki; and Dr. Kiyoyuki Tokuyama, Tokuyama Clinic, Okinawa.
Compliance with ethical standards
Conflict of interest
Dr. Okada is funded by Takeda Pharm., Chugai Pharm., Kyowa-Hakko Kirin, Pfizer, Boehinger Ingelheim, Astellas Pharm., Otsuka Pharm., MSD, Shionogi, Novaltis, Sumitomo Dainippon Pharm., Mitsubishi Tanabe Pharm., and Daiichi Sankyo Co. Dr. Robinson and Dr. Pisoni are members of Clinical Research for the non-profit organization Arbor Research Collaborative for health, which has designed and carried out the Dialysis Outcomes and Practice Pattern Study (DOPPS) Program. The DOPPS program is supported by Amgen, Kyowa Hakko Kirin, AbbVie Inc., Sanofi Renal, Baxter Healthcare, and Vifor Fresenius Medical Care Renal Pharma Ltd. Additional support for specific projects and countries is also provided in Canada by Amgen, BHC Medical, Janssen, Takeda, Kidney Foundation of Canada (for logistics support); in Germany by Hexal, DGfN, Shire, WiNe Institute; and for the Peritoneal-DOPPS in Japan by the Japanese Society for Peritoneal Dialysis (JSPD). The DOPPS.org website lists the full details. JDOPPS was administered by the Arbor Research Collaborative for Health, Ann Arbor, MI, USA, and supported by Kyowa Hakko Kirin Co. Ltd. All support is provided without restrictions on publications. All other authors have no conflict disclosure.
Human and animal rights
The study’s protocol was approved by the Tsukuba institutional review board (IRB) (H27-199) and the review board of the Japanese Society of Nephrology (No. 29), and has been or will be approved by the IRB of each participating facility. The study procedures fully adhered to the Declaration of Helsinki and the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement, and was registered with the University Hospital Medical Information Network (UMIN000022145).
Informed consent was and will be obtained from all individual participants included in the study.
The study was supported by a Grant-in-Aid for Research on Advanced Chronic Kidney Disease, Practical Research Project for Renal Diseases from the Japan Agency for Medical Research and Development, AMED. Preparation of the manuscript was supported in part by JH’s grant from Grants-in-Aid for Scientific Research (JSPS KAKENHI) Grant Number 15K08719, and the Okinaka Memorial Institute.
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