Predicting the outcome of chronic kidney disease by the estimated nephron number: The rationale and design of PRONEP, a prospective, multicenter, observational cohort study

BMC Nephrology

Study Protocol

Takashi Nakazato¹  Takashi Kenmochi²  Ryo Nakajima²  Hiroo Ikehira²  Hiroshi Kitamura²  Motonobu Nishimura²  Hiroyuki Fujikawa²  Takehiko Kawaguchi²  Toshiyuki Imasawa³  Ritsuko Katafuchi⁴  Tsuyoshi Yamamura⁵  Mitsuhiro Yoshimura⁶  Kensei Yahata⁷  Akira Shimatsu⁷  Masaru Nakayama⁸  Osamu Sasaki⁹  Takaaki Yaomura^1,10  Takahito Ito^1,11  Yutaka Ando^1,12 

[1] National Hospital Organization Chiba Medical Center, Chiba, Japan;National Hospital Organization Chiba-East Hospital, Chiba, Japan;National Hospital Organization Chiba-East Hospital, Chiba, Japan;Department of Nephrology, National Hospital Organization Chiba-East Hospital, 675, Nitona-cho, Chuoh-ku, 460-8712, Ciba-city Chiba, Japan;National Hospital Organization Fukuoka-Higashi Medical Center, Fukuoka, Japan;National Hospital Organization Hokkaido Medical Center, Hokkaido, Japan;National Hospital Organization Kanazawa Medical Center, Kanazawa, Japan;National Hospital Organization Kyoto Medical Center, Kyoto, Japan;National Hospital Organization Kyusyu Medical Center, Fukuoka, Japan;National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan;National Hospital Organization Nagoya Medical Center, Nagoya, Japan;National Hospital Organization Osaka Medical Center, Osaka, Japan;National Hospital Organization Osaka-Minami Medical Center, Osaka, Japan;

关键词: Chronic kidney disease;    Nephron number;    Birth weight;    A prospective;    Multicenter;    Observational cohort study;    Kidney biopsy;    Glomerular density;    Cortex volume;   

DOI  :  10.1186/1471-2369-13-11

 received in 2012-01-31, accepted in 2012-03-10,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundThe nephron number is thought to be associated with the outcome of chronic kidney disease (CKD). If the nephron number can be estimated in the clinical setting, it could become a strong tool to predict renal outcome. This study was designed to estimate the nephron number in CKD patients and to establish a method to predict the outcome by using the estimated nephron number.Methods/DesignThe hypothesis of this study is that the estimated nephron number can predict the outcome of a CKD patient. This will be a multicenter, prospective (minimum 3 and maximum 5 years follow-up) study. The subjects will comprise CKD patients aged over 14 years who have undergone a kidney biopsy. From January 2011 to March 2013, we will recruit 600 CKD patients from 10 hospitals belonging to the National Hospital Organization of Japan. The primary parameter for assessment is the composite of total mortality, renal death, cerebro-cardiovascular events, and a 50% reduction in the eGFR. The secondary parameter is the rate of eGFR decline per year. The nephron number will be estimated by the glomerular density in biopsy specimens and the renal cortex volume. This study includes one sub-cohort study to establish the equation to calculate the renal cortex volume. Enrollment will be performed at the time of the kidney biopsy, and the data will consist of a medical interview, ultrasound for measurement of the kidney size, blood or urine test, and the pathological findings of the kidney biopsy. Patients will continue to have medical consultations and receive examinations and/or treatment as usual. The data from the patients will be collected once a year after the kidney biopsy until March 2016. All data using this study are easily obtained in routine clinical practice.DiscussionThis study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. Furthermore, this is the first prospective study to examine whether the nephron number predicts the outcome of CKD patients. The results from this study should provide powerful new tools for nephrologists in routine clinical practice.Trial registrationUMIN-Clinical Trial Registration, UMIN000004784.

【 授权许可】

CC BY   
© Imasawa et al; licensee BioMed Central Ltd. 2012