Clinical and Experimental Nephrology

, Volume 14, Issue 2, pp 144–151

Design and methods of a strategic outcome study for chronic kidney disease: Frontier of Renal Outcome Modifications in Japan


    • Department of Nephrology, Institute of Clinical Medicine, Graduate School of Comprehensive Human SciencesUniversity of Tsukuba
  • Hirofumi Makino
    • Department of Medicine and Clinical ScienceOkayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
  • Tadao Akizawa
    • Division of Nephrology, Department of MedicineShowa University School of Medicine
  • Kunitoshi Iseki
    • Dialysis UnitUniversity Hospital of The Ryukyus
  • Sadayoshi Itoh
    • Division of Nephrology, Endocrinology and Vascular MedicineTohoku University Graduate School of Medicine
  • Kenjiro Kimura
    • Department of Nephrology and HypertensionSt. Marianna University School of Medicine
  • Daisuke Koya
    • Division of Endocrinology and MetabolismKanazawa Medical University
  • Ichiei Narita
    • Division of Clinical Nephrology and RheumatologyNiigata University Graduate School of Medical and Dental Science
  • Tetsuya Mitarai
    • Division of Nephrology and Hypertension, Saitama Medical CenterSaitama Medical School
  • Masanobu Miyazaki
    • Department of Internal MedicineMiyazaki Clinic
  • Yoshiharu Tsubakihara
    • Department of NephrologyOsaka General Medical Center
  • Tsuyoshi Watanabe
    • Department of Internal Medicine IIIFukushima Medical University School of Medicine
  • Takashi Wada
    • Department of Laboratory Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Faculty of MedicineKanazawa University
  • Osamu Sakai
    • Japan Kidney Foundation
  • Advisory Committee for FROM-J
Original Article

DOI: 10.1007/s10157-009-0249-4

Cite this article as:
Yamagata, K., Makino, H., Akizawa, T. et al. Clin Exp Nephrol (2010) 14: 144. doi:10.1007/s10157-009-0249-4



The continuous increase in the number of people requiring dialysis is a major clinical and socioeconomical issue in Japan and other countries. This study was designed to encourage chronic kidney disease (CKD) patients to consult a physician, enhance cooperation between nephrologists and general practices, and prevent the progression of kidney disease.


Subjects comprise CKD patients aged between 40 and 74 years consulting a general physician, and patients in CKD stage 3 with proteinuria and diabetes or hypertension. This trial is a stratified open cluster-randomized study with two intervention groups: group A (weak intervention) and group B (strong intervention). We have recruited 49 local medical associations (clusters) in 15 different prefectures, which were classified into four regions (strata) based on the level of increase rate of dialysis patients. The patients in group A clusters were instructed initially to undergo treatment in accordance with the current CKD treatment guide, whereas patients in group B clusters were not only instructed in the same fashion but also received support from an information technology (IT)-based system designed to help achieve the goals of CKD treatment, consultation support centers, and consultations by dietitians visiting the local general practice offices. We assessed the rates of continued consultation, collaboration between general practitioners and nephrologists, and progression of CKD (as expressed by CKD stage).


Through this study, filling the evidence-practice gap by facilitating effective communication and supporting general physicians and nephrologists, we will establish a CKD care system and decrease the number of advanced-stage CKD patients.


Chronic kidney diseaseEvidence-practice gapCluster-randomized studyEducational interventionCooperation between nephrologists and general physicians

Copyright information

© Japanese Society of Nephrology 2009